We provide comprehensive services for formal health technology assessment (HTA). Our extensive experience includes all major markets that require health technology assessment submissions. Based on your needs, we can provide a full package of research and dossier production, or contribute specific components of the research or submission package.
We are experienced in all aspects of the research required to support HTA submissions. We prepare research plans to meet the needs of individual products including scope of work, costs, and timescales. We help clients identify the likely relevant comparators in major markets, understand the value of their new products in relation to comparators, and plan the research necessary to provide convincing evidence of value for formal HTA submissions. Based your requirements, the HTA strategy could be a stand-alone project or part of a comprehensive market access and outcomes research strategy.
We provide formal evaluations of HTAs for other products. As part of our review we identify the underlying factors that resulted in a positive or negative assessment.
We interview payers to identify reimbursement issues that should be considered in the value arguments for your technology. Results from payer research may identify evidence gaps in value propositions. Our clients use our payer research reports to inform their pricing and market access strategies.
We develop cost-effectiveness and cost-utility models that demonstrate the likely cost-effectiveness of a new product in relation to relevant comparators. Our clients use the models to explore alternative scenarios for price and efficacy. We identify gaps in the availability of high-quality data that will be required for models. For example, utility weights may not be available. This helps clients plan the research needed to fully support their products in a formal HTA submission.
Our experience in utility research includes EQ-5D, time trade-off, standard gamble, and other methods, using patient and general population samples. Our project teams include experts in survey and clinical research as well as in statistics. We provide high-quality study design, data collection and analysis in a timely manner.
We collect data on resource use and outcomes via medical record abstraction, database studies, surveys, Delphi panels, and prospective observational studies. Our experience spans single-country and multi-country studies in the major European markets and North America.
We help clients establish the optimum design for collection of EQ-5D and resource-use data in trials, and we provide appropriate analysis of the data for inclusion in economic models. We develop and implement analysis plans of patient-level data or can advise our clients' statistics groups if they analyzed the data.
We conduct systematic reviews of clinical evidence for formal HTA submissions. Reviews are performed according to a pre-specified protocol and are fully documented, including the searches, study selection, trial quality assessment, data extraction and reporting.
We conduct systematic reviews to support the selection of utility weights, resource use, and costs for HTA models. Reviews are performed according to a pre-specified protocol and are fully documented, including the searches, study selection, trial quality assessment, data extraction, and reporting.
Our biometrics group provides meta-analysis and indirect and mixed treatment comparisons for economic analyses and HTA submissions. Statistical analysis plans are designed with input from health economists to ensure that analyses are integrated with the needs of economic models. Uncertainty in the clinical data, such as retaining covariance, is fully described to allow it to be fully reflected in the economic model (i.e., in probabilistic sensitivity analysis).
Our biometrics group works with our health economists to perform analyses of patient-level data that are required specifically for economic analysis such as parametric survival modeling and subgroup analyses.
We develop cost-effectiveness, cost-utility and budget impact models for formal HTA submissions. We provide full detailed reports that cover all the information required for submissions. Our quality assurance procedures encompass input data, programming, calculations, and senior review to ensure that our submission models are of the highest quality.
We apply standard procedures to ensure the clinical validity and quality of our models. To validate model predictions, we compare model results with original trial data and, where possible, relevant external evidence. Our quality assurance procedures encompass input data, programming, calculations, and senior review to ensure that our submission models are of the highest quality.
Our models are programmed to allow univariate and multivariate sensitivity analysis for all key model parameters. Probabilistic sensitivity analysis applies the distribution of the source data as far as possible, or generally accepted distributional forms for individual types of data.
Our team of professional medical writers works with our technical specialists to prepare succinct, optimal, and comprehensive presentations of the evidence that are consistent with the value messages for your products.
We identify the value of new products relative to comparators and develop value messages. These value messages are included in submission dossiers to ensure that the full value of products is conveyed to decision makers and other audiences.
Our technical and document-production teams are available to assist in developing responses to requests for clarification, assessment reports, and preliminary recommendations.
