Essential to the success of clinical pathways is transparency of the development process. This includes transparency regarding the clinical evidence reviewed, the economic evaluations made, and the process by which clinical and cost information is synthesized in order to arrive at the prioritization of one treatment over another. The two feature articles published in this month’s issue shed light on some of the practices that go into the development of a clinical pathway.
Given today’s financial constraints, health care decision-makers are faced with the challenge of assessing the economic value of different treatment agents for placement within clinical pathways. For example, epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer (NSCLC) is a specific lung cancer subtype that has shown sensitivity to treatment with EGFR tyrosine kinase inhibitors (TKIs). Two TKIs, afatinib and erlotinib, have shown benefits versus standard chemotherapy in patients with metastatic NSCLC with EGFR Del19 mutation. Afatinib, an irreversible EGFR TKI, is the only TKI to demonstrate statistically significant progression-free survival and overall survival benefits, whereas erlotinib, a reversible EGFR TKI, has demonstrated significant improvement in progression-free survival but not overall survival.
In order to better understand the effects of prolonged survival with these treatment options on costs and health outcomes, Jonathan Graham, BS, et al developed a decision model to evaluate the direct costs, outcomes, and cost-effectiveness of treating with afatinib and erlotinib in patients with metastatic NSCLC with EGFR Del19 mutations (page 31). The authors’ approach demonstrates an effective means of bringing together cost and clinical outcomes information in order to compare the overall relative value of two treatments for a given patient population.
Many stakeholders have called for greater transparency regarding the process by which consensus-driven, evidence-based clinical pathways are developed. To address this need, Bruce Feinberg, DO, and colleagues held a mock clinical pathway development simulation to provide an opportunity for interested stakeholders to observe the processes by which oncologists make determinations including initial and subsequent diagnostic tests critical to treatment selection, timing and extent of such testing, the most appropriate treatment for each line of therapy, definition of treatment failure, and criteria for subsequent treatment selection (page 41). In the simulation, a group of medical oncologists/hematologists created pathways for the treatment of chronic-phase chronic myeloid leukemia, coming to a consensus for patient stratification and first-, second-, and third-line treatment selection for low/intermediate- and high-risk patients.
Going forward, transparency of the evidence synthesis and clinical pathway development processes will be key to ensuring buy-in among stakeholders of the pathways concept.
