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PP149 Features Of Accountable And Reasonable Processes For Coverage Decision-Making
- Monika Wagner, Dima Samaha, Roman Casciano, Matthew Brougham, Charles Petrie, Payam Abrishami, Bernard Avouac, Paul Kind, Lorenzo Giovanni Mantovani, Antonio Sarria-Santamera, Michael Schlander, Michele Tringali
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 125
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Introduction:
The Accountability for Reasonableness (A4R) framework addresses the legitimacy of coverage decision processes by defining four conditions for accountable and reasonable processes: Relevance, Publicity, Appeals, Implementation. Cost-per-quality-adjusted life year (QALY) and multicriteria-centered processes may have distinct implications for meeting A4R conditions. The aim of this study was to reflect on how the diverse features of decision-making processes can be aligned with A4R conditions to guide legitimized decision-making. Rare disease and regenerative therapies (RDRTs) pose special decision-making challenges and offer a useful case study.
Methods:To support reflection on how different approaches address the A4R conditions, thirty-four features operationalizing each condition were defined and organized into a matrix. Seven experts from six countries explored and discussed these features during a panel (Chatham House Rule) and provided general and RDRT-specific recommendations for each feature. Responses were analyzed to identify converging and diverging recommendations.
Results:Regarding Relevance, panelists highlighted the importance of supporting deliberation, stakeholder participation and grounding coverage decision criteria in the legal framework, goals of sustainable healthcare and population values. Among seventeen criteria, thirteen were recommended by more than half of panelists. Although the cost-effectiveness ratio was deemed sometimes useful, the validity of universal thresholds to inform allocative efficiency was challenged. Regarding Publicity, panelists recommended communicating the values underlying a decision in reference to broader societal objectives, and being transparent about value judgements in selecting evidence. For Appeals, recommendations included clear definition of new evidence and revision rules. For Implementation, one recommendation was to perform external quality reviews of decisions. While RDRTs raise issues that may warrant special consideration, rarity should be considered in interaction with other aspects (e.g. disease severity, age, budget impact).
Conclusions:Improving coverage decision-making towards accountability and reasonableness involves supporting participation and deliberation, enhancing transparency, and more explicit consideration of multiple decision criteria that reflect normative and societal objectives.
A pharmacoeconomic evaluation of major depressive disorder (Italy)
- Julian Casciano, Steven Arikian, Jean-Eric Tarride, John J. Doyle, Roman Casciano
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- Journal:
- Epidemiologia e Psichiatria Sociale / Volume 8 / Issue 3 / September 1999
- Published online by Cambridge University Press:
- 11 October 2011, pp. 220-231
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Objective – To determine the most cost-effective oral therapy for the treatment of Major Depressive Disorder (MDD) in Italy. Method – We conducted a pharmacoeconomic evaluation based on a decision analytic model that examined the treatment of major depressive disorder (MDD) in Italy. The analysis compared the serotonin norepinephrine reuptake inhibitor (SNRI), venlafaxine extended-release (venlafaxine XR), to selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs). A meta-analysis was performed to determine the clinical rates of success. The meta-analytic rates were applied to the decision analytic model to calculate the expected cost and expected outcomes for each anti-depressant comparator. Cost-effectiveness was determined using the expected values for both a successful outcome, and a composite measure of outcome termed ‘symptom-free days’. A policy analysis was conducted to estimate the financial impact to the Servizio Sanitario Nazionale (SSN). Results – Treatment of MDD with venlafaxine XR yielded the highest overall efficacy rates for outpatients (73.7%) versus SSRIs (61.4%) and TCAs (59.3%), and inpatients (62.3%) versus SSRIs (58.6%) and TCAs (58.2%). Venlafaxine XR had the lowest dropout rates due to lack of efficacy (4.8%) versus SSRIs (8.4%) and TCAs (6.8%), and adverse drug reactions (10.9%) versus SSRIs (17.4%) and TCAs (23.1%). Initiating treatment of MDD with venlafaxine XR yielded the lowest expected cost for outpatients and for inpatients. The total resulting savings for the SSN at a 5% venlafaxine XR utilization was estimated between L 963 million and L 3,210 million. Conclusion – This study confirms that venlafaxine XR is generally a cost-effective treatment of MDD. Additionally, the results of this investigation suggest that increased utilization of venlafaxine XR will favorably impact the SSN.
Impact of Rivastigmine on Costs and on Time Spent in Caregiving for Families of Patients With Alzheimer's Disease
- Deborah Marin, Karine Amaya, Roman Casciano, Katherine L. Puder, Julian Casciano, Sobin Chang, Edward H. Snyder, Isaac Cheng, Anthony J. Cuccia
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- Journal:
- International Psychogeriatrics / Volume 15 / Issue 4 / December 2003
- Published online by Cambridge University Press:
- 10 January 2005, pp. 385-398
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Background: Alzheimer's disease (AD) places a significant burden on health care systems worldwide. As new treatments are developed, their cost-effectiveness is often assessed to help health care professionals make informed decisions. In addition to the more common practice of assessing direct medical costs, indirect costs, including time spent in caregiving, should be evaluated. Methods: This study examined the potential effects of the dual cholinesterase inhibitor rivastigmine (Exelon) on caregivers of patients with AD. Results from two 26-week, placebo-controlled trials have demonstrated the clinically relevant and statistically significant efficacy of rivastigmine (6–12 mg/day) compared to placebo, on cognition, activities of daily living, and global functioning. By delaying progression of AD, significant savings in caregiver burden are anticipated, as measured by time spent caregiving and its related costs. Data collected in a prospective, observational study of AD patients and their caregivers were used to establish the relationship between disease severity (based on Mini-Mental State Examination [MMSE] score) and time spent caregiving (according to the 5-item Caregivers Activity Survery score). A significant correlation was observed between the two scores (N = 43, r = −.56, p < .0001), demonstrating that more time for supervision from caregivers is required as the disease progresses. This finding was used to estimate the reduced caregiver burden resulting from the delay in disease progression that was demonstrated with use of rivastigmine. Results: Over a 2-year period, the reduction in time spent in caregiving reached 691 hours for caregivers of patients with mild AD (MMSE score 21–30), resulting in a total savings of approximately $11,253. Treatment of patients with moderately severe AD was also evaluated. The trend was similar but the impact was less, suggesting an economic benefit to early therapy. Conclusion: Early diagnosis and a pharmacologic intervention that allows the patients to remain at home longer by delaying disease progression would have a beneficial impact on patients, caregivers, and payers, and should therefore be encouraged through initiatives designed to identify and treat patients early in the course of disease.