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Clinical Economics Resource Links

Policy Projects

Evaluation of the Academy for Managed Care Pharmacy Format for Formulary Submissions
Deliberative Focus Groups: Citizen Input to Health Policy

Evaluation of the Academy for Managed Care Pharmacy Format for Formulary Submissions

Principal Investigator: Peter J. Neumann

This evaluation will assess the impact of a new process for formulary decision makers to obtain information, including cost-effectiveness information, on drug products that are being considered for inclusion on formularies. The project goal is to facilitate and guide improvements in this process.

The investigators will audit dossier submissions at three selected health plans that have adopted formulary guidelines in order to understand the content, completeness, and quality of information submitted by drug companies, focusing on the extent to which dossiers contain standardized information consistent with the recommendations from the Academy of Managed Care Pharmacy and assessing the potential of the information to mislead payers.

For each dossier, the investigators will collect background information to use in understanding the extent to which the drug is a "breakthrough innovation" or a drug that is similar to others. The dossier analysis will then address questions including:

1. Are submitted dossiers complete? (Do they contain standardized information consistent with recommendations of the AMCP Format? Which Format sections are typically included? Which are omitted? What is the composition of the dossiers in terms of clinical information versus economic data? Does dossier quality vary by type of drug—e.g., are dossiers more complete for expensive innovative products than for "me-too" drugs?)
2. What is the potential for dossier information to mislead health plans? (To what extent do dossiers contain information on off-label drug uses? To what extent do they include data from unpublished studies? To what extent do they include economic models, which can incorporate claims not directly related to the approved indication? To what extent do economic models incorporate claims not directly related to the approved indication?
3. What is the quality of the economic models contained in the dossiers? (Do the economic models adhere to good modeling practices? Are the models transparent? Do investigators discount future costs and health benefits?)
4. Is there evidence that drug companies are submitting the same information to multiple plans?

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Deliberative Focus Groups: Citizen Input to Health Policy

Principal Investigator: Marthe R. Gold

This project is working toward an innovative and effective approach for allowing public citizens to provide informed input into resource allocation decisions. The House Appropriation Committee Report encourages ´óÏóÊÓƵto "make easily accessible the findings of existing, scientifically sound, cost-effectiveness studies of new clinical interventions and technologies," with the goal of integrating these studies more effectively into decision processes. However, the perception that the public opposes consideration of cost in decisions about the use of new, often expensive interventions and technologies limits efforts to develop useful approaches to policy regarding these technologies. In fact, informed public opinion may have much more nuance than that.

This project will review and develop methods for tapping informed public opinion as an input to these decisions, to facilitate the effective utilization of cost-effectiveness information to inform policy choices with regard to new technologies and interventions.

The project will identify a case concerning the coverage of a technology or clinical intervention by Medicare or a private insurer. The intervention identified will pose concerns relative to cost, effectiveness, and/or cost-effectiveness—i.e., the technology will be one that imposes a significant cost and positive health benefit on at least one dimension relative to existing alternatives.

The investigators will develop materials for informing citizen members of focus groups concerning the issues relevant to coverage of this technology, including issues of cost, comparative effectiveness, cost-effectiveness, and equity. They will convene a citizens' focus group and explore members' ability, interest, and comfort with providing input on the coverage decision before and after their review of the informative materials.

The investigators will analyze the views obtained from members, considering the dimensionality and content of responses and the impact of reviewing and reflecting on the informative materials on their decision process. Their report will include questions to address and suggestions for process improvements in a future, more comprehensive investigation of the performance of citizens' focus groups and recommendations for steps required to develop and implement this approach for using citizen groups to provide input into resource allocation decisions.

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