ISPOR Europe 2018
Barcelona, Spain
November, 2018
PMH69
Mental Health
Patient-Reported Outcomes & Patient Preference Studies (PRO)
Health States/Utilities (HS)
QUALITY OF LIFE ACCORDING TO RESPONDER RATE IN OPIOID DEPENDENT ADULTS RECEIVING TREATMENT WITH BUPRENORPHINE DEPOT INJECTIONS (CAM2038) VERSUS SUBLINGUAL BUPRENORPHINE/NALOXONE
Jensen R1, Rasmussen MA2, Frost M3, Budilovsky-Kelley N4, Kim S5, Tiberg F1
1Camurus AB, Lund, Sweden, 2University of Copenhagen, Gentofte, Denmark, 3The Frost Medical Group, Conshohocken, PA, USA, 4Braeburn, Plymouth Meeting, PA, USA, 5Braeburn, Philadelphia, PA, USA
OBJECTIVES: Investigational CAM2038 for the treatment of opioid use disorder (OUD) offers a novel approach to management of opioid dependence that improves treatment outcomes, reduce risks of misuse and diversion. In this presentation, the link between reduction in illicit opioid use, treatment modalities and QALYs is assessed.

METHODS: Safety and efficacy of CAM2038 was evaluated in two studies: A Phase 3, 48-week, multinational, open-label trial (OLT), and a Phase 3, 24-week, outpatient, multicenter, randomized, double-blind, double-dummy controlled trial (RCT) versus SL-BPN/NX. The primary endpoint in the RCT was based on negative urine toxicology confirmed by self-report. Information on QALYs is collected in the OLT with the EQ-5D-5L. By combining QALYs from OLT, published and adjusted data on QALYs in patients on SL-BPN, efficacy data from the RCT we estimated QALYs for CAM2038 versus SL-BPN/NX over a 24-week period.

RESULTS: The EQ-5D-5L surveys (n=1254) were split into responder groups (q1-4) on rates of negative urine samples (0-100%)confirmed by self-reports and showed the following distribution (n0-25% = 178, n26-50% = 146, n51-75% = 114, n76-100% = 816). Mean QALYs for responder groups differed (p < 0.001). In total 428 subjects (nCAM2038=213, nSL-BPN/NX = 215) from the RCT were used to evaluate the efficacy in an intention to treat (ITT) analysis. Similar to OLT, responder groups were established in the RCT. Based on the QALYs from the OLT, QALYs from SL-BPN/NX treatment, efficacy data from the RCT, the estimated QALYs over the 24 weeks’ trial are inferred to be 0.3726 and 0.4437 for SL BPN/NX and CAM2038, respectively.

CONCLUSIONS: The analysis showed that under reasonable assumptions, treatment with CAM2038 generates substantial improvement in QALYs over a six-month treatment versus SL-BPN/NX. Further research is warranted to quantify the difference in QALYs between treatment with CAM2038 versus oral BPN based products in a real-life setting.