ISPOR Europe 2018
Barcelona, Spain
November, 2018
PMH74
Mental Health
Patient-Reported Outcomes & Patient Preference Studies (PRO)
Quality-of-Life (hrQoL), Health States/Utilities (HS)
QUALITY OF LIFE ACCORDING TO TEMPORAL ILLICIT OPIOID USE AND RESPONDER RATE IN ADULTS RECEIVING BUPRENORPHINE DEPOT INJECTIONS (CAM2038) TO TREAT OPIOID USE DISORDER IN A 48-WEEK OPEN LABEL STUDY
Rasmussen MA1, Frost M2, Jensen R3, Budilovsky-Kelley N4, Kim S5, Tiberg F3
1University of Copenhagen, Gentofte, Denmark, 2The Frost Medical Group, Conshohocken, PA, USA, 3Camurus AB, Lund, Sweden, 4Braeburn, Plymouth Meeting, PA, USA, 5Braeburn, Philadelphia, PA, USA
OBJECTIVES: Investigational weekly and monthly buprenorphine depot (CAM2038) for treatment of opioid use disorder (OUD) offers a novel approach to patient management. The potential of CAM2038 to improve health related quality of life (hrQoL) and Quality Adjusted Life Years (QALYs) are important criteria for decision makers to consider in evaluating cost effectiveness of new treatments in OUD and is assessed in this research.

METHODS: The long-term safety of investigational CAM2038 was evaluated in a Phase 3, 48-week, open-label study in patients with moderate to severe OUD. A post hoc responder rate was defined according to the proportion of urine toxicology tests testing negative for illicit opioids including self-reported (SR) illicit opioid use, evaluated at quartiles(q1-4). HrQoL was evaluated with the EQ-5D-5L in order to derive QALYs for each responder rate. Trends in EQ-5D-5L scores were evaluated descriptively with respect to responder rates and temporal abuse.

RESULTS: A total of 188 subjects (out of 228 enrolled, 82%) with at least a single EQ-5D-5L survey were included for analysis. The surveys were collected from week 20 to week 48 with an average of 6.7 surveys per participant. EQ-5D-5L index scores were positively correlated to clean urine toxicology test/SR with an average of 0.05 +/- 0.01 points higher hrQoL score for clean urine toxicology tests/SR (p = 0.01). The subjects were split in responder groups defined by response of q1 (n = 26, 14%), q2 (n = 21, 11%), q3 (n = 18, 10%), and q4 (n = 123, 65%). The responder groups EQ-5D-5L averages were 0.88, 0.86, 0.90, and 0.92 respectively and statistically different (p < 0.001).

CONCLUSIONS: Although careful interpretation is warranted due to trial design, this analysis demonstrated hrQoL and QALY improvement related to both individual temporal illicit opioid use as well as overall groups of responders.