Compendia Developing a compendia strategy is a key step to understanding appropriate patient access to needed treatments for non-labeled indications. Because Medicare, Medicaid, and private payers may refer to the compendia when making coverage decisions, a positive or a negative listing can have a significant impact on whether a product is covered, thus ultimately affecting prescribing decisions and patient access. Compendia Significantly Used to Facilitate Access in Both Oncology and Non-oncology ProductsView Item Compendia-related consulting services include: Compendia Benchmarking Analysis Provide a landscape overview of the key compendia and their related review processes, including a discussion of compendia rating systems and their translation to coverage and reimbursement Assesses comparator products for compendia listings (indications, ratings, recommendations) relative to the target product for competitive insight Establish the foundation for a Benchmarking Analysis Benchmarking Analysis Provide an assessment of current compendia evidentiary thresholds that are cited within the compendia specific to the therapeutic area of interest by evaluating comparator products to benchmark data requirements Conduct a thorough clinical literature review of comparator products to identify benchmarks (eg, study design, drugs and dosages, eligibility criteria, primary and secondary endpoints, primary and secondary efficacy, safety, and journal publications) Establish the foundation for a Gap Analysis Gap Analysis Provide an assessment of the target product’s clinical trial literature within its therapeutic area and compares the data to the evidentiary thresholds obtained in the Benchmarking Analysis Evaluate the evidence level, strength of endpoints, and outcomes as available for the target product’s use relative to compendia benchmarks for comparator products Provide recommendations regarding any identified informational gaps, differences in clinical data and supporting information, and compendia submission planning strategy Establish the foundation for a Submission PackageSubmission Package Submission Package Draft narratives to compendia of interest requesting the addition of a recent FDA-approved indication for the target product Draft narratives to compendia of interest for accepting an off-label use supported by sufficient and appropriate evidence Draft requests to compendia of interest for overturning unfavorable listings Surveillance Track and monitor compendia listings of the target product and comparator products to evaluate for updates to uses and the planning of future studies Payer Utilization & Trends Analysis Conduct payer-specific research to understand how insurers (e.g. Medicaid plans and/or private payers) utilize compendia for coverage determinations Provide recommendations toward targeted compendia outreach strategies as needed based on research conducted and trends identified With a specialized team of compendia consultants and dozens of completed projects through partnerships with various manufacturers, Xcenda has the expertise to provide strategic and tactical support to compendia planning objectives. Start a conversation.