Patrizio Armeni

Real-world cost effectiveness of MitraClip combined with Medical Therapy Versus Medical therapy alone in patients with moderate or severe mitral regurgitation

BACKGROUND We evaluated the real-world cost-effectiveness of the MitraClip system (Abbott Vascular Inc., Menlo Park, CA) plus medical therapy for patients with moderate/severe mitral regurgitation, as compared with medical therapy (MT) alone. METHODS Clinical records of patients with moderate to severe functional mitral regurgitation treated with MitraClip (N=232) or with MT (N=151) were collected and outcome analyzed with propensity score adjustment to reduce selection bias. Twelve-month outcomes were modeled over a lifetime horizon to conduct a cost-effectiveness analysis, in the payers perspective. Costs and benefits were discounted at an annual rate of 3.5%. RESULTS After propensity score adjustment, the average treatment effect was -9.5% probability of dying at 12months and, following lifetime modeling, 3.35±0.75 incremental life years and 3.01±0.57 incremental quality-adjusted life years. MitraClip contributed to a higher decrease in re-hospitalizations at 12months (difference=-0.54±0.08) and generated a more likely improvement in the New York Heart Association (NYHA) class at 12months versus NYHA at enrollment. Incremental costs, adapted to five possible scenarios, ranged from 14,493 to 29,795 € contributing to an incremental cost-effectiveness ratio ranging from 4796 to 7908 €. CONCLUSIONS Compared to MT alone and given conventional threshold values, MitraClip can be considered a cost-effective procedure. The cost-effectiveness of MitraClip is in line or superior to the one of other non-pharmaceutical strategies for heart failure.

What type of clinical evidence is needed to assess medical devices

The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable. We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction. We describe a case study concerning a cost-effectiveness analysis based on real-world data of a technology already in use: Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate-to-severe mitral regurgitation. The CEA has encountered the scepticism of most reviewers, due not to the statistical methodology but to the fact that the study was observational and not experimental. Editors and reviewers converged in considering real-world economic evaluations premature in the absence of a RCT, even if in the meantime the technology had been implanted >30 000 times. We believe there is a need to acknowledge the importance of real-world studies, and engage the scientific community in the promotion and use of clinical evidence produced through observational studies. Real-world data are a valid complement and/or alternative to RCTs to support policy decisions on medical devices http://ow.ly/SHsZ300pfCB

The impact of HTA and procurement practices on the selection and prices of medical devices

Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices. This paper focuses on medical devices (MDs) and investigates the combined effect of various HTA governance models and procurement practices on the two steps of the MD purchasing process (i.e., selecting the product and setting the unit price). Our analyses are based on primary data collected through a national survey of Italian public hospitals. The Italian National Health Service is an ideal case study because it is highly decentralized and because regions have adopted different HTA governance models (i.e., regional, hospital-based, double-level or no HTA), often in combination with centralized regional procurement programs. Hence, the Italian case allows us to test the impact of different combinations of HTA models and procurement programs in the various regions. The results show that regional HTA increases the probability of purchasing the costliest devices, whereas hospital-based HTA functions more like a cost-containment unit. Centralized regional procurement does not significantly affect MD selection and is associated with a reduction in the MD unit price: on average, hospitals located in regions with centralized procurement pay 10.1% less for the same product. Hospitals located in regions with active regional HTA programs pay higher prices for the same device (+23.2% for inexpensive products), whereas hospitals that have developed internal HTA programs pay 8.3% on average more for the same product.

Multiprofessional Primary Care Units: What Affects the Clinical Performance of Italian General Practitioners?

Multiprofessional primary care models promise to deliver better care and reduce waste. This study evaluates the impact of such a model, the primary care unit (PCU), on three outcomes. A multilevel analysis within a “pre- and post-PCU” study design and a cross-sectional analysis were conducted on 215 PCUs located in the Emilia-Romagna region in Italy. Seven dimensions captured a set of processes and services characterizing a well-functioning PCU, or its degree of vitality. The impact of each dimension on outcomes was evaluated. The analyses show that certain dimensions of PCU vitality (i.e., the possibility for general practitioners to meet and share patients) can lead to better outcomes. However, dimensions related to the interaction and the joint works of general practitioners with other professionals tend not to have a significant or positive impact. This suggests that more effort needs to be invested to realize all the potential benefits of the PCU’s multiprofessional approach to care.

Market access management by pharmaceutical companies in a complex environment: The Italian case study

Market access for pharmaceuticals has become a key issue in the Italian National Health Service, for at least three reasons: (i) market access delays are very high in Italy compared to other countr...

The simultaneous effects of pharmaceutical policies from payers' and patients' perspectives: Italy as a case study.

ObjectivesThis paper aims at covering a literature gap on the effects of copayments, prescription quotas and therapeutic reference pricing on public and private expenditures and volumes (1) When these policies are implemented in different areas at different times, (2) estimating their impact in the short and long run, (3) assessing the extent to which these impacts are interdependent, (4) scrutinising the extent to which the effects are mediated by prescribers’ and patients’ behaviours.MethodsMonthly regional data on pharmaceutical expenditures, volumes and policies in Italy from 2000 to 2014 are analysed using a difference-in-differences model enriched to capture short- versus long-term effects and simultaneous and interactive effects. Sobel–Goodman test and bootstrap analyses were used to test for mediation.ResultsThe three policies have different short- and long-run effects. Interactions support the hypothesis of reinforcing effects. Behavioural reactions to policies such as reducing the demand or total per capita expenditures mediate the impact of policies, thus explaining the different effects between the short and long term.ConclusionsEvidence on the impact over time of regional policies diversely introduced in different times have important policy implications. First, pharmaceutical policies interact with each other, and the combined effect may be different from what we would expect from the sum of each single policy. Hence, policymakers should be very careful in designing mixed policies for their unexpected combined effects. Second, the impact of policies tends to reduce over time. If longer-term impact is desired, it would be appropriate to introduce some adjustments over time. Third, policies have multiple effects, and this should be considered when they are designed. Finally, pharmaceutical policies may have an unintended impact on health and health care.

Comparative effectiveness of Mitraclip plus medical therapy versus medical therapy alone in high-risk surgical patients: A comprehensive review

In recent years, Mitraclip has become available as a treatment option for mitral regurgitation in high-risk surgical patients. Focusing on the incremental effectiveness of Mitraclip versus the current standard of care, this article provides a comparative review of the evidence on Mitraclip and standard medical therapy (MT) in high-risk mitral regurgitation patients. Evidence was retrieved from seven major databases. Results suggest that Mitraclip presents a high safety profile and a good middle-term effectiveness performance. Evidence on long-term effectiveness is limited both for Mitraclip and MT. Few studies allow a comparison with MT and comparative results on different endpoints are mixed. Therefore, the available evidence does not conclusively inform whether or under which circumstances Mitraclip should be preferred over MT in the treatment of high-risk patients. Head-to-head real-world studies would be needed, as they would provide great and timely insights to support policy decisions when medical devices are at stake.

Myth #1: The Healthcare System Is Failing

Many people say that Health Care Systems are not financially sustainable and so they are all ultimately doomed.

Variations in non-prescription drug consumption and expenditure: Determinants and policy implications

This paper analyses the determinants of cross-regional variations in expenditure and consumption for non-prescription drugs using the Italian Health Care Service as a case study. This research question has never been posed in other literature contributions. Per capita income, the incidence of elderly people, the presence of distribution points alternative to community pharmacies (para-pharmacies and drug corners in supermarkets), and the disease prevalence were included as possible explanatory variables. A trade-off between consumption of non-prescription and prescription-only drugs was also investigated. Correlation was tested through linear regression models with regional fixed-effects. Demand-driven variables, including the prevalence of the target diseases and income, were found to be more influential than supply-side variables, such as the presence of alternative distribution points. Hence, the consumption of non-prescription drugs appears to respond to needs and is not induced by the supply. The expected trade-off between consumption for prescription-only and non-prescription drugs was not empirically found: increasing the use of non-prescription drugs did not automatically imply savings on prescription-only drugs covered by third payers. Despite some caveats (the short period of time covered by the longitudinal data and some missing monthly data), the regression model revealed a high explanatory power of the variability and a strong predictive ability of future values.

A meta-analysis of MitraClip combined with medical therapy versus medical therapy alone for treatment of mitral regurgitation in heart failure patients

Survival benefit of percutaneous mitral valve repair with the MitraClip over conservative treatment of functional mitral regurgitation (MR) remains unclear. The purpose of this meta‐analysis is to compare survival outcomes of MitraClip with those of medical therapy in patients with functional MR.