Jason R. Guertin

Transcatheter Aortic Valve Implantation: Recommendations for Practice Based on a Multidisciplinary Review Including Cost-Effectiveness and Ethical and Organizational Issues

Transcatheter aortic valve implantation (TAVI) is a relatively new technology for the treatment of severe and symptomatic aortic valve stenosis. TAVI offers an alternative therapy for patients unable to be treated surgically because of contraindications or severe comorbidities. It is being rapidly dispersed in Canada, as it is worldwide. The objective of this article is to present our recommendations for the use of TAVI, based on a multidisciplinary evaluation of recently published evidence. We systematically searched and summarized published data (2008-2011) on benefits, risks, and cost-effectiveness of TAVI. We also examined ethical issues and organizational aspects of delivering the intervention. We discussed the soundness and applicability of our recommendations with clinical experts active in the field. The published TAVI results for high-risk and/or inoperable patients are promising in terms of survival, function, quality of life, and cost-effectiveness, although we noted large variability in the survival rates at 1 year and in the frequency of important adverse outcomes such as stroke. Until more data from randomized controlled trials and registries become available, prudence and discernment are necessary in the choice of patients most likely to benefit. Patients need to be well-informed about gaps in the evidence base. Our recommendations support the use of TAVI in the context of strict conditions with respect to patient eligibility, the patient selection process, organizational requirements, and the tracking of patient outcomes with a mandatory registry.

Savings from the use of a probiotic formula in the prophylaxis of antibiotic-associated diarrhea

Abstract Objective: Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-associated diarrhea (CDAD) are the most common causes of healthcare associated infectious diarrhea. A double-blind, dose response, placebo-controlled trial of the probiotic formula (Bio-K+ Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R formula) for prophylaxis of AAD and CDAD was published in 2010. The Bio-K+ Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R formula is a registered trademark of Bio-K Plus International Inc. (Laval, Québec, Canada). Results indicated that the incidence of AAD and CDAD were lower for patients assigned to the probiotic formula compared with the placebo option. The present study aims to estimate the savings in direct medical costs that might result from the use of two different doses of the probiotic formula vs placebo. Methods: A cost-consequence analysis was conducted to compare the two doses of the probiotic formula compared to placebo. The analysis was based upon published data and adjusted to the North American context. Results: Economic analyses showed that the use of the probiotic formula would result in estimated mean per patients savings of US

Cost effectiveness of 'on demand' HIV pre-exposure prophylaxis for non-injection drug-using men who have sex with men in Canada.

1968 for the single dose and US

Challenge of Informing Patient Decision Making

2661 for the double dose compared with the placebo option if used an average of 13 days by all patients at risk of developing AAD and CDAD. Limitations: Several key parameters considered within the economic model were not captured within the Gao et al. study. Numerous sensitivity analyses were conducted to address this issue. Conclusion: The use of the probiotic formula in prophylaxis of AAD and CDAD would lead to estimated savings in direct medical costs that would substantially offset its acquisition cost. Treating 1000 hospitalized patients on antibiotics with the double dose of the product compared to current practice would save a single payer system the sum of

Atrial Fibrillation and Congestive Heart Failure: A Cost Analysis of Rhythm-Control vs Rate-Control Strategies

2,661,218.

The potential economic impact of restricted access to angiotensin-receptor blockers

Pre-exposure prophylaxis for individuals who are at high risk for HIV infection has been shown to be effective at preventing infection. The authors of this article aimed to investigate whether ‘on-demand’ pre-exposure prophylaxis is also cost effective, specifically in Canada in a population of men who have sex with men, who are at higher risk for HIV infection. The authors used multiple methods to generate a thorough cost-effectiveness analysis that has implications for the use of this therapy in Canada.

Economic Evaluation Of A Pharmacogenomic Test For Statin-Induced Myopathy In Cardiovascular High-Risk Patients Initiating A Statin.

In the management of advanced heart failure, the option of long-term mechanical circulatory support (MCS) as destination therapy (DT), rather than as a temporary bridge to cardiac transplantation, is increasingly being offered to highly selected patients. Recent technological advancements in implantable devices, such as continuous flow systems and smaller pump sizes, have increased the possibility of survival with fewer complications. Informed consent before MCS is essential1–6 and is a fundamental aspect of patient-centered care. As a part of a quality decision-making process, the patient considering MCS and his/her informal caregiver(s) need to be aware of the current state of the scientific evidence, including what is known and unknown about outcomes and living with MCS and must navigate a series of interactions with clinicians before deciding on the treatment course. Editorial see p 13 The Institut National d’Excellence en Sante et en Services Sociaux is a health technology assessment and clinical guideline development organization in the province of Quebec (Canada) that provides multiple stakeholders (ie, government officials, hospital administrators, physicians, and patient organizations) with evidence-based information. In 2011, the Quebec Ministry of Health requested that the Institut National d’Excellence en Sante et en Services Sociaux provide recommendations on the use of implantable left ventricular assist devices in end-stage chronic heart failure. The current article extends the work submitted to the Ministry1 and focuses on MCS use in DT, within the framework of informed decision making. In this perspective piece, we report on our review of the scientific literature concerning clinical outcomes in DT and on perspectives of DT patients and their caregivers, to provide a summary of currently available information and identify gaps in knowledge. Besides the use of MCS as a bridge to transplantation, we do not consider in this perspective the other clinical recourses to …

Bias within economic evaluations - the impact of considering the future entry of lower-cost generics on currently estimated incremental cost-effectiveness ratios of a new drug.

BACKGROUND Atrial fibrillation (AF) is common in patients with heart failure. Rhythm- and rate-control strategies are associated with similar efficacy outcomes. We compared the economic impact of the 2 treatment strategies in patients with AF and heart failure from the province of Québec, Canada. METHODS In a substudy of the Atrial Fibrillation and Congestive Heart Failure trial, health care expenditures of patients from Québec randomized to rhythm and rate-control treatment strategies were compared from a single-payer perspective using a cost-minimization approach. In-trial resource utilization and unit costs were estimated from Québec Health Insurance Board databases supplemented by disease-specific costs from the Ontario Case Costing Initiative. RESULTS In all, 304 patients were included, aged 68 ± 9 years; 86% male; ejection fraction, 26% ± 6%. Baseline characteristics were similar in rhythm-control (n = 149) and rate-control (n = 155) groups. Arrhythmia-related costs accounted for 45% of total expenditures. Rate-control patients had fewer cardiac procedures (146 vs. 238, P < 0.001), driven by fewer cardioversions, and lower costs related to antiarrhythmic drugs (CAD

Value of a Hypothetical Pharmacogenomic Test for the Diagnosis of Statin-Induced Myopathy in Patients at High Cardiovascular Risk

48 per patient [95% confidence interval {CI},

Maximal expected benefits from lowering cholesterol in primary prevention for a high-risk population

21-