Health Economics and Outcomes Research (HEOR) teams are using evidence aggregation platforms to conduct observational and retrospective studies using both clinical trial results and real world data. Whether a single database is being used for analysis or a combination of multiple datasets are combined, the best evidence aggregation platforms will incorporate standardized analytics that allow for efficient and effective insight generation. One of the key resources a HEOR team needs is the ability to standardize the downstream medical costs of drug adverse events.
An example of how HEOR teams are using evidence generation platforms can be seen at a top tier pharmaceutical company who was preparing the launch of a new antipsychotic into a competitive market where perception was that the tolerability of treatments is adequately managed with atypical antipsychotics (AAPs).
The study used an evidence aggregation platform to examine the FDA Adverse Event Reporting System (FAERS) in order to establish the level and costs of post-marketing AAP-related adverse events reported since 2008. Proprietary analytics contained in the evidence aggregation platform were used to calculate the downstream medical costs of AAP adverse events. This was done by mapping adverse events to MedDRA Preferred Terms, which were then matched to corresponding ICD-9 codes. Adverse events that were identified as serious events according to the EudraVigilance list of Important Medical Events (IME) were included in the estimates of total costs of adverse events. National hospitalization and aggregate costs for some events not included as serious IMEs were obtained using the Healthcare Cost and Utilization Project (HCUP) data.
The results concluded that activation-, sedation-, and weight gain-related adverse events continue to persist, thereby warranting a need for additional tolerable and efficacious treatment alternatives, and that these adverse events have costly implications for both patients and payers.
These data, methodology, and results were included in a poster presentation at a top tier conference.
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Jim Davis, EVP Advera Health Analytics