The Clinical and Reimbursement Landscape of Immuno-Oncology - Episode 1

Determining the Place of PD-1s in Therapy

In this first segment of a one-on-one interview, a part of the Oncology Stakeholders Summit, Spring 2015 series, Michael Kolodziej, MD, and Bruce Feinberg, DO, address some of the key issues payers face as they make coverage decisions on the new PD-1 drug class of immuno-oncology agents.

Dr Kolodziej, national medical director of oncology strategy for Aetna, points out that prescribing behavior has thus far reflected the indications tested during the clinical trial process and, to a lesser extent, where National Comprehensive Cancer Network (NCCN) places them in the treatment guidelines for melanoma and now non-small cell lung cancer. Similarly, payers’ coverage policies reflect approved labeling and the NCCN recommendations.

If they reach their fullest potential, PD-1 inhibitors may be used to target up to 30 different tumor types, says Dr Feinberg, vice president and chief medical officer of Cardinal Health Specialty Solutions. They both agree that a key challenge to successful treatment outcomes with PD-1 inhibitors and for appropriate coverage decision making will be overcoming the lack of biomarkers to determine who will most benefit with these agents.

Dr Feinberg emphasizes that the FDA labeling and NCCN recommendations restrict use of PD-1 agents to patients who have suffered relapses. He believes that the excitement over this drug class, on both the provider and patient levels, will drive the use of these agents earlier in treatment.

The problem, according to Dr Kolodziej, is that clinical evidence on the optimal use of PD-1 inhibitors may lag behind actual use. Such new drug classes, he thinks, may require reconsideration of the way evidence is collected to help not only informed patient care but also coverage policy.

Watch our related Peer Exchange, Oncology Stakeholders Summit, Spring 2015.