Development of Seasonal Influenza Vaccination Recommendations: Relevance and Influence of the Evidence on the Decision-Making Process in France and the Netherlands.

BACKGROUND: Target groups for seasonal influenza vaccination are defined at the country level and are based on several factors. However, little is known about the national decision-making procedures. OBJECTIVE: The purpose of this study was to compare the evidence used for the development of recommendations and its impact on the choice of target groups in France and the Netherlands. METHODS: A preliminary documentary analysis identified institutions to include in the assessment: governmental authorities, research institutions, associations, and manufacturers. At least one expert from each group was invited to our study. Thirty-three semi-structured interviews were conducted in 2013 (16 France, 17 the Netherlands). We used NVivo10® to perform a thematic content analysis. RESULTS: Clinical/epidemiological studies were the evidence most used in both countries. Economic models were increasingly being used; these had greater influence on the decision making in the Netherlands than in France, probably because of the presence of a modeler. Generally, the quality of the evidence used was poor, although no systematic use of standard protocol for its assessment was observed. A general protocol was sometimes used in France; however, the personal judgment of the experts was crucial for the assessment in both countries. CONCLUSIONS: There were differences in the target groups, for example, pregnant women, recommended only in France. France and the Netherlands use similar evidence for developing vaccination recommendations, although different decisions are sometimes made regarding target groups. This could be associated with the lack of systematic standard appraisals, increasing the influence of the experts' judgment on decision making. The development of standards for the appraisal of evidence is recommended.

Impact of the healthcare payment system on patient access to oral anticancer drugs: an illustration from the French and United States contexts.

BACKGROUND: Oral anticancer drugs (OADs) allow treating a growing range of cancers. Despite their convenience, their acceptance by healthcare professionals and patients may be affected by medical, economical and organizational factors. The way the healthcare payment system (HPS) reimburses OADs or finances hospital activities may impact patients' access to such drugs. We discuss how the HPS in France and USA may generate disincentives to the use of OADs in certain circumstances. DISCUSSION: French public and private hospitals are financed by National Health Insurance (NHI) according to the nature and volume of medical services provided annually. Patients receiving intravenous anticancer drugs (IADs) in a hospital setting generate services, while those receiving OADs shift a part of service provision from the hospital to the community. In 2013, two million outpatient IADs sessions were performed, representing a cost of €815 million to the NHI, but positive contribution margin of €86 million to hospitals. Substitution of IADs by OADs mechanically induces a shortfall in hospital income related to hospitalizations. Such economic constraints may partially contribute to making physicians reluctant to prescribe OADs. In the US healthcare system, coverage for OADs is less favorable than coverage for injectable anticancer drugs. In 2006, a Cancer Drug Coverage Parity Act was adopted by several states in order to provide patients with better coverage for OADs. Nonetheless, the complexity of reimbursement systems and multiple reimbursement channels from private insurance represent real economic barriers which may prevent patients with low income being treated with OADs. From an organizational perspective, in both countries the use of OADs generates additional activities related to physician consultations, therapeutic education and healthcare coordination between hospitals and community settings, which are not considered in the funding of hospitals activities so far. SUMMARY: Funding of healthcare services is a critical factor influencing in part the choice of cancer treatments and this is expected to become increasingly important as economic constraints grow. Drug reimbursement systems and hospital financing changes, coupled with other accompanying measures, should contribute to improve equal and safe patient access to appropriate anticancer drugs and improve the management and care pathway of cancer patients.

Influenza vaccination policy-making processes in France and The Netherlands: Framework and determinants.

OBJECTIVES: Target groups for seasonal influenza vaccination are nationally defined based on several factors. However, few studies have explored the policy-making processes at the country-level. We investigated key differences in the policy-making process for the development of vaccination recommendations between France (FR) and The Netherlands (NL). This paper presents preliminary results on the evidence used in the decision-making process and focuses on the interactions between the experts and stakeholders. METHODS: A documentary analysis identified the stakeholders of this process as governmental authorities, research institutions, associations, and manufacturers. This qualitative study included at least one expert from each stakeholder group. Thirty-three semi-structured interviews were performed in 2013 (16 FR, 17 NL). We used NVivo10® to perform a thematic content analysis on the data. RESULTS: National Immunization Technical Advisory Groups (NITAGs) were the key stakeholders in the development of recommendations. There was no systematic standard evaluation of evidence during the decision-making process in both countries. Likewise, voting was not systematic, although it did occur more often in FR. A declaration of interests was obligatory in both countries. Experts with no conflicts of interest were rare because many depend on private funding for their research on influenza vaccination. CONCLUSIONS: The transparency of the NITAGs' procedures for the development of recommendations should be improved. We believe improvements might be achieved by the systematic standard evaluation of evidence, consistent voting, clear declarations of interest, and increased public funding for vaccination research.

Concordance rate differences of 3 noninvasive imaging techniques to measure carotid stenosis in clinical routine practice: results of the CARMEDAS multicenter study.

BACKGROUND AND PURPOSE: To replace digital subtraction angiography (DSA) in carotid stenosis evaluation, noninvasive imaging techniques have to reach a high concordance rate. Our purpose is to compare the concordance rates of contrast-enhanced MR angiography (CEMRA) and CT angiography (CTA) with Doppler ultrasound (DUS) in clinical routine practice. METHODS: We evaluated prospectively with DUS, CEMRA, and CTA 150 patients suspected of carotid stenosis. The overall concordance rates of the 3 techniques were calculated for symptomatic stenosis > or =50% and > or =70%, for asymptomatic stenosis > or =60%, and for occlusion. For the carotid arteries treated by surgery (n=97), the results of each method and combined techniques were recorded, and misclassification rates were evaluated from surgical reports. RESULTS: The overall concordance rates of DUS-CEMRA, DUS-CTA, and CEMRA-CTA were not statistically different. However, the concordance rate of DUS-CEMRA (92.53%) was significantly higher than that for DUS-CTA (79.10%) in the surgical asymptomatic stenosis group (P=0.0258). CTA considered alone would misclassify the stenosis in a significant number of cases (11 of 64) in the surgical asymptomatic group compared with CEMRA (3 of 67) and DUS (1 of 66) (P=0.0186 versus MRA, P=0.0020 versus DUS). CONCLUSIONS: With the techniques as utilized in our study, the overall concordance rates of combined noninvasive methods are similar for measuring carotid stenosis in clinical routine practice, but in asymptomatic carotid stenosis, the decision making for surgery is significantly altered if DUS and CTA are considered in place of DUS and CEMRA.

Budget impact analysis of the use of oral and intravenous anti-cancer drugs for the treatment of HER2-positive metastatic breast cancer.

OBJECTIVES: Two anti-cancer drugs are currently approved for the treatment of HER2-positive metastatic breast cancer (MBC): trastuzumab-based therapy (TBT) administered intravenously as first line therapy until disease progression and lapatinib, an oral self-administered dual therapy with capecitabine (L+C) as second intention for patients who continue to progress despite TBT. In current practice, TBT is still prescribed beyond disease progression. In addition to medical reasons, the difficulty to switch eligible patients to oral drugs may also be explained by economic reasons. Thus, we aimed at comparing the budgetary impact of TBT and L+C for progressing HER2+MBC after TBT from the French Health Insurance perspective. METHODS: A budget impact analysis was performed on a 3-year time horizon (2012-2014) to simulate a dynamic cohort of 4182 HER2-positive patients with a progressing MBC treated with TBT (73%) and L + C (27%). The model was adjusted on progression-free survival (PFS). Office visits, clinical evaluations, drug acquisition, administration costs, and transportation costs obtained from the literature and published databases were considered. RESULTS: In the base case analysis (2012), the annual treatment cost per patient for TBT (€36,077) was 2-times higher than that of L + C (€17,165). Using L + C for all patients (n = 4182) would avoid €34.8 million of drug administration and transportation costs. Hospital costs represented 1% vs 88%, while community costs represented 99% vs 12% of L + C and TBT treatment costs, respectively. The lack of direct comparison PFS and treatment dosage modification data were the main limitations. However, no major changes from baseline results were observed from sensitivity analyses. CONCLUSIONS: Despite a slightly higher acquisition cost, the treatment cost of L + C remains lower than that of TBT, and it is the only approved anti-HER2 treatment for HER2-positive patients with progressing MBC. Based on this, it seems important to consider the potential savings for Health Insurance with the use of oral drug due to the reduction of outpatient hospitalizations. Such reductions may result in a subsequent budget reduction for hospitals, but may also provide those facing acute medical activity with opportunities to better manage other diseases whose treatment cannot be externalized.