Evidence Evaluation & Value Assessment
In the big European markets, healthcare systems are under acute financial pressure. The market for new medical technologies is more austere, more demanding, and more scrutinized than in the past. A variety of responsible stakeholders and the service provider want to know what kind of value a new medical technology provides, i. e. you will have to demonstrate:
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What patient benefit your medical technology offers compared to standard treatment options,
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that your technology is cost-effective, even if it is more expensive than the gold standard, and
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which budget impact the coverage of your product will have.
TARESO HEALTHCARE advises you as to what kind of value information on clinical efficacy and cost impact you should have available, when and for whom.
Rapid evidence evaluation
A rapid evidence evaluation provides a balanced assessment of the current quantitatively and qualitatively available data of your innovative medical technology with respect to patient benefit, medical necessity and economic rationales.
The evidence evaluation includes:
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"Quick" literature scans, assessing and identifying key items of the available evidence.
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Internal benefit assessment to identify, what relevant authorities would expect to see.
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A gap analysis as an aid in determining how to move forward with evidence development where data is lacking (critique of existing protocols or input into new study designs).
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In depth literature and guideline research including a systematic review of the published evidence.
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Review and grading of both the quantity and quality of the available studies according to accepted scientific methodologies and as required by authorities.
Development of a strong value story
The development of a comprehensive value story for your medical technology is a prerequisite for reimbursement and marketing activities. A logical compiled value story, supported with the best available data for clinical and economic effectiveness could be a very convincing argument for a quick introduction into the healthcare market. Key perspectives to develop a value story for your product would be:
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Looking at the clinical effectiveness: Improved patient outcomes, reduced readmissions, reduced adverse events, reduced hospital acquired infections, increased patient safety, improved patient experience/satisfaction, reduced length of stay
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Looking at the economic effectiveness: Reduced cost, increased revenue, higher ROI
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Looking at operational outcomes: Reduced staff burden, more efficient inventory management, higher staff satisfaction, increased product and system uptime, increased staff efficiency, increased product utilization
Creation of a comprehensive core value dossier
The Core Value Dossier as a comprehensive document presents a detailed analysis of the related disease background as well as of clinical, humanistic and economic values of your new technology. The dossier is prepared as a basic outline which can be further customized for submissions to relevant authorities and payers.
The structure of the value dossier varies slightly by medical technology but the themes throughout are focused to support the consistent brand value story, composed of multiple value messages:
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Burden of disease
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Epidemiology of disease
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Treatment pathways
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Overview of the new technology
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Key clinical evidence
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Systematic review
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Economic evidence and cost-effectiveness arguments
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Humanistic evidence and summary of outcomes