SIMULATION MODEL OF IBRUTINIB IN TREATMENT OF RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL)
Author(s)
Peng S1, Sorensen S1, Pan F1, Dorman E1, Sun S2, Van Sanden S3, Sengupta N4, Gaudig M5
1Evidera, Bethesda, MD, USA, 2Janssen, Pharmaceutical Companies of Johnson and Johnson, Raritan, NJ, USA, 3University Hospital Leuven, Leuven, Belgium, 4Janssen Pharmaceuticals, Inc, Raritan, NJ, USA, 5Janssen Pharmaceuticals, Inc, Neuss, Germany
OBJECTIVES For patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), prognosis is poor, with a median survival of one to two years, and treatment options are very limited. In a recent phase II trial (PCYCY-1104), Ibrutinib (Imbruvica™), a first-in-class oral once a day covalent Bruton’s tyrosine kinase inhibitor, was associated with a median progression-free survival (PFS) of 13.9 months. After a median follow-up of 15.3 months, 63% of patients were alive. The aim of the current study was to evaluate the projected life years (LYs) and quality-adjusted LYs (QALYs) associated with ibrutinib and other treatments for R/R MCL. METHODS Patients with R/R MCL were simulated to receive treatment in a health state, survival partition model. Patients received ibrutinib,bendamustine and rituximab (BR), fludarabine, mitoxantrone, and cyclophosphamide (FMC), temsirolimus, or other comparators until death or until progression of disease, at which point they were modeled to receive a subsequent line of treatment or best supportive care. Clinical inputs for ibrutinib were informed by PCYC-1104 trial data; OS was extrapolated to estimate survival outcomes. Clinical inputs for comparators were informed by published sources identified through a systematic literature review. Utility values were informed by published studies. Outcomes were discounted by 3.5%. RESULTS Treatment with ibrutinib resulted in better health outcomes, incrementally increasing overall LYs by 0.92, 0.86, and 0.92 and PFS LYs by 0.87, 0.87, and 0.87 compared to BR, FMC, and temsirolimus, respectively. Ibrutinib was associated with 0.71, 0.70, and 0.72 overall incremental QALYs compared to BR, FMC, and temsirolimus, respectively. CONCLUSIONS Compared with other therapies, Ibrutinib yielded an average incremental benefit of 0.90 LYs for R/R MCL patients, largely driven by the significant incremental improvement in duration of PFS. Currently a phase III trial is ongoing, the data from which will be used to validate the model.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PCN38
Topic
Clinical Outcomes
Topic Subcategory
Relating Intermediate to Long-term Outcomes
Disease
Oncology