Access Evidence
Access Evidence is any evidence that establishes a pharmaceutical therapy or device's value and is used to support patients, healthcare providers, payers, policymakers, and other stakeholders with decisions regarding reimbursement, utilization, and patient access to the therapy or device.:[1] Access Evidence includes, but is not limited to, the following[2][3]
- Data describing populations at risk of a disease or health event
- Epidemiology of disease (e.g., incidence, prevalence)
- Disease and severity risk factors
- Clinical characteristics of populations affected by the disease or health event
- Descriptions and occurrence of short and long-term sequelae
- Treatment patterns and standard of care in a given disease or therapeutic area
- Clinical outcomes (e.g., efficacy/effectiveness, safety)
- Humanistic outcomes (e.g., psychosocial impacts, health-related quality of life, patient satisfaction)
- Economic outcomes (e.g., direct and indirect costs and resource utilization)
- Cost-effectiveness, budget impact, and other modeled economic impacts
Access Evidence is generated and summarized through a variety of methods including, but not limited to, the following:
- Clinical trial data, real-world evidence
- Prospective or retrospective studies (e.g., medical record abstraction, cross-sectional surveys, prospective registries, retrospective database analyses, cohort studies, case-control studies)
- Health preference studies
- Systematic literature reviews
- Meta-analyses, indirect treatment comparisons
- Economic modeling
References
- ↑ Ducournau, Pierre (2019). "Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company". Int J Technol Assess Health Care. 35 (1): 10–16. doi:10.1017/S0266462318003653. PMC 6521787 Check
|pmc=value (help). PMID 30789111. - ↑ Henshall, Chris (2013). "Health technology assessment, value-based decision making, and innovation". Int J Technol Assess Health Care. 29 (4): 353–9. doi:10.1017/S0266462313000378. PMID 23845404. Unknown parameter
|s2cid=ignored (help) - ↑ Lakdawalla, Darius (2018). "Defining Elements of Value in Health Care-A Health Economics Approach: An ISPOR Special Task Force Report [3]". Value Health. 21 (2): 131–139. doi:10.1016/j.jval.2017.12.007. PMID 29477390. Unknown parameter
|s2cid=ignored (help)
This article "Access Evidence" is from Wikipedia. The list of its authors can be seen in its historical and/or the page Edithistory:Access Evidence. Articles copied from Draft Namespace on Wikipedia could be seen on the Draft Namespace of Wikipedia and not main one.
