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Institute for Clinical and Economic Review

Describe an overview of ICER 

ICER, the Institute for Clinical and Economic Review, is a well-defined independent organization that accounts for the cost-effectiveness and value of healthcare interventions. Some of the models adopted include medications and medical technologies with the objective of sustainable care (Gerlach et al., 2020). Manufacturers often seek to understand ICER’s findings to support the coverage of their products by large payer groups, such as insurance companies or government healthcare programs. It ensures quality assurance between the stakeholders.

Methodology Used in Conducting an ICER Report

ICER conducts rigorous assessments using a transparent and standardized methodology. The process typically involves the following steps:

Scoping: ICER defines the scope of the assessment, specifying the population, interventions, comparators, outcomes, and time frame under consideration.

Systematic Review: checking on comprehensive Review prevailing alongside clinical evidence, published studies, and trial data to help understand effectiveness and safety profile in the general scope

Cost-effectiveness Analysis: ICER evaluates the cost-effectiveness using approaches such as quality-adjusted life years (QALYs) alongside others.

Budget Impact Analysis: ICER assesses the potential budget impact of adopting the intervention on the overall healthcare system, considering factors such as prevalence, utilization, and pricing.

Stakeholder Engagement: It involves discussion that sees the patients, clinicians, manufacturers, and payers have been incorporated into diverse perspectives of the assessment and report drafting followers.

Opportunity for the Manufacturer to Engage with ICER

Manufacturers have the opportunity to engage with ICER at different stages of the assessment process:

Scoping: Manufacturers can provide input during the scoping phase to ensure that relevant outcomes, comparators, and patient populations are considered in the assessment.

Clinical Evidence: Manufacturers can submit additional or updated clinical evidence to supplement the systematic Review conducted by ICER (Kruzikas et al., 2020).

Modeling and Analyses: Manufacturers can share their economic models and analyses, which ICER may consider in its evaluation of the intervention’s cost-effectiveness.

Stakeholder Input: Manufacturers can participate in ICER’s public meetings and provide perspectives on the intervention’s value, addressing questions related to its clinical benefits, patient experience, and overall impact on healthcare.

Output Included in ICER Reports

Clinical Effectiveness: ICER summarizes the existing clinical evidence, including the intervention’s efficacy, safety, and impact on patient outcomes.

Cost-effectiveness Analysis: ICER presents the results of the cost-effectiveness analysis, including ICER values, which represent the additional cost incurred for each additional unit of health outcome gained.

Recommendations: ICER provides recommendations based on its assessments, suggesting pricing benchmarks and potential policy implications for payers and other stakeholders.

Methodology Used in Conducting an ICER Report

ICER conducts rigorous assessments using a transparent and standardized methodology. The process typically involves the following steps:

Scoping: ICER defines the scope of the assessment, specifying the population, interventions, comparators, outcomes, and time frame under consideration.

Systematic Review: ICER conducts a comprehensive review of existing clinical evidence, including published studies and trial data, to understand the intervention’s effectiveness and safety profile.

Cost-effectiveness Analysis: ICER evaluates the cost-effectiveness of the intervention by comparing its clinical benefits and potential harms against its costs.

Budget Impact Analysis: ICER assesses the potential budget impact of adopting the intervention on the overall healthcare system, considering factors such as prevalence, utilization, and pricing.

Stakeholder Engagement: ICER solicits input from various stakeholders, including patients, clinicians, manufacturers, and payers, to incorporate diverse perspectives into the assessment.

Opportunity for the Manufacturer to Engage with ICER

Manufacturers have the opportunity to engage with ICER at different stages of the assessment process:

Scoping: Manufacturers can provide input during the scoping phase to ensure that relevant outcomes, comparators, and patient populations are considered in the assessment.

Clinical Evidence: Manufacturers can submit additional or updated clinical evidence to supplement the systematic Review conducted by ICER(Kruzikas et al., 2020).

Modeling and Analyses: Manufacturers can share their economic models and analyses, which ICER may consider in its evaluation of the intervention’s cost-effectiveness.

Stakeholder Input: Manufacturers can participate in ICER’s public meetings and provide perspectives on the intervention’s value, addressing questions related to its clinical benefits, patient experience, and overall impact on healthcare.

 Output Included in ICER Reports

ICER reports include several key components:

Clinical Effectiveness: ICER summarizes the existing clinical evidence, including the intervention’s efficacy, safety, and impact on patient outcomes.

Cost-effectiveness Analysis: ICER presents the results of the cost-effectiveness analysis, including ICER values, which represent the additional cost incurred for each additional unit of health outcome gained.

Budget Impact: ICER assesses the potential budget impact of adopting the intervention, providing insights into the economic implications for healthcare payers.

Recommendations: ICER provides recommendations based on its assessments, suggesting pricing benchmarks and potential policy implications for payers and other stakeholders.

How payer groups may use the output from ICER

The outputs from ICER reports, such as cost-effectiveness analyses, budget impact assessments, and stakeholder perspectives, provide critical information that payer groups consider in their coverage decisions. Payer groups use ICER reports to make informed decisions about whether to include a specific pharmaceutical product in their formulary, which is a list of medications covered by an insurance plan (Peter J. et al., 2021). The cost-effectiveness analysis helps them assess the value of the drug in relation to its cost. Negotiations with manufacturers and resource allocation help in allocating resources effectively within their budget constraints.

Importance and Utilization of ICER Reports by Payers

ICER reports play a significant role in the healthcare landscape, providing evidence-based assessments that inform decision-making processes. Payers often use ICER reports as part of their decision-making toolkit, alongside other factors such as clinical trial data, real-world evidence, and expert opinions. The importance of ICER reports lies in their ability to offer a standardized and systematic evaluation of a drug’s clinical and economic value. By providing comprehensive analyses and recommendations, ICER reports assist payers in making more informed, transparent, and equitable decisions about coverage and reimbursement.

Research conducted over the years has shown that payers do consider ICER reports when making coverage decisions. Many payers find value in the independent, unbiased assessments provided by ICER, which help them assess the relative value of different treatment options.

References

Gerlach, J. A., Snow, B., Prioli, K. M., & Ronald Vertsman, R. (2020). Analysis of stakeholder engagement in the public comments of ICER draft evidence reports. PubMed Central (PMC). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737724/

Kruzikas, D. S., Malone,, D. C., & Pham, S. (2020). HTA and economics in the United States: A systematic review of ICER reports to evaluate trends, identify factors associated with recommendations, and understand implications. PubMed Central (PMC). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10391276/

Peter J., N., Joshua T., C., & Daniel A, O. (2021). Institute for clinical and economic Review. The Right Price, 112-141. https://doi.org/10.1093/oso/9780197512883.003.0006

 

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