A Drug Company finds itself with a real world problem – their drug is in a Tier 3 formulary position with unfavorable pricing that is leading to slower adoption than anticipated.  The Drug Company convenes a panel of four payers to see what evidence might be needed to improve their formulary position to Tier 2 or even Tier 1.  Three alternatives are presented and Celéri Health’s Real World Outcomes® Platfrorm was chosen to be the real world evidence that the payors would use to make their decision of formulary position for this particular drug. Come talk to us about how we can help you  make better decisions in paying for outcomes.

Ethos Labs Foundation Pain Index (FPI) has developed a composite score comprised of a panel of eleven functional pain biomarkers, which is based on the abnormal biochemistry described in a population study of over 17,000 patients on opioids for chronic pain. The Celéri Health Real World Outcomes platform was used to cross-validate these results with PROs to better understand the daily lives of individuals with chronic pain in the context of their biomarker profiles. The result of the analysis detailing the corroboration between the FPI and PROMIS-29 in real-world patients noted significant associations with multiple domains, including physical function, pain impact score, fatigue, pain interference, and depression. This validates the utility of the FPI for identifying the composite chronic pain state. Continued research is underway to calibrate this approach so as to define next step in clinical decision making.

Celéri Health is being used to study objective measures for changes in pain sensitivity. Due to limited tools to objectively quantify pain clinically, clinicians rely on patient reported scales to determine pain treatment options (e.g.,opioid dosage is typically to the patient’s estimate of pain). Without an objective test of pain sensitivity, a kind of “blood pressure” equivalent to pain, treatment decisions rely on patients claims of pain, which may be based on the patient’s desire for treatments due to addiction or anxiety about pain that they experience as intolerable. Patients know that if they report more pain, it is likely that their physician will prescribe more pain medication. For this reason, objective tests for pain sensitivity are needed to assess patients complaints with precision.

The Celéri Health platform is being used in conjunction with the Muse S (choosemuse.com) biofeedback training device to assess impact on quality of life using PROs, bio-signals (EEG, HRV, Cerebral SpO2), and pain tolerance and sensitivity using a cold pressor test.  This multichannel data capture study will allow us to objectively correlate bio-signals of pain with the patient’s mood, sleep, and function is currently underway. Further information can be found here at Clinicaltrials.gov.