PCORI to Compare Hep C Treatments

While aiming to sidestep specific cost controversies, the Patient-Centered Outcomes Research Institute (PCORI) is launching a $50 million program to fund research on the comparative effectiveness of various approaches for diagnosing and treating hepatitis C. The organization’s charter blocks it from supporting studies on comparative health care and treatment costs, but this research project is likely to provide ammunition for all sides of the debate on pharmaceutical pricing.

PCORI is soliciting research proposals in four priority areas, including head-to-head comparisons of different oral antivirals and comparisons of screening and testing strategies to detect disease. The program also will examine the pros and cons of starting treatment immediately after diagnosis, compared to “watchful waiting.” A number of health plans, payers and public health programs are limiting access to newer high-priced medicines to those patients with full-blown disease, while delaying treatment for those testing positive but not yet displaying symptoms. Research indicating that this approach is harmful or ultimately more costly would undermine delay strategies approaches designed to reduce outlays for hep C medications.

Patient groups have been particularly vocal in opposing randomized clinical trials on the benefits and risks of delayed treatment when they consider the evidence so dramatic on the efficacy of new therapies, noted PCORI executive director Joe Selby at the recent meeting on advancing ethical research sponsored by PRIM&R (Public Responsibility in Medicine & Research). Selby emphasizes that costs are not part of PCORI’s purview, but state Medicaid officials and patient groups continue to raise concerns about budget-breaking drug costs and too-high out-of-pocket requirements. The planned research program aims to inform the debate, while carefully avoiding direct cost issues.

The handing of this role to PCORI was one aspect of the “four point plan” to create a shared dialogue with pharma companies developed by Steve Miller of Express Scripts. Miller and Express Scripts are profiled in the latest issue of Pharmaceutical Executive.