Andrew L. Pecora, MD
It is almost unimaginable. Oncologists have waited for decades to offer their patients a better chance of surviving cancer, and now they can—for multiple cancer types. In unleashing the natural immune response to “foreign” antigens produced by malignant cells, we have shown conclusively that antibodies directed against so-called immune checkpoints (immuno-oncology drugs) can improve both progression-free survival and overall survival in a growing variety of cancer types. Because the immune system is capable of recognizing and reacting to any foreign antigen regardless of the tissue of origin of the malignancy, it is likely that indications for immuno-oncology drugs will continue to expand. Patients treated with immuno-oncology drugs are living longer and better than those who preceded the development of these agents. So, what could possibly be wrong with this story? Cost and reimbursement. As our story on this issue indicates, a new class of payer denials has emerged.
A growing chorus of complaints is manifesting across the country as payers absorb and react to the significance of this new class of expense—that the advances in outcomes are unquestionable and covered patients are demanding these costly drugs. The first wave of payer policy push-back, after liberal approvals and payments for immuno-oncology drugs, has been strict adherence to FDA approval guidelines. Precise indications including stage, ECOG performance status, dosage, total dose, and dose intervals are being scrutinized, resulting in waves of denials across the country. As one can imagine, denials can occur after the fact, with drugs being administered and then paid for only partially. For providers, the great expense of immuno-oncology drugs leaves little room for reimbursement shortfalls, particularly in the community setting. Next up will be controversy regarding the broader use of PD-L1 expression as an arbiter of approval. This soon will be followed by policy that addresses the duration of therapy in the metastatic setting. Approvals on combination therapy and retreatment for progression after response will further confuse the reimbursement story.
We all know that growth in expenditures in healthcare, particularly oncology, is not sustainable. We must remain vigilant, however, that we not confuse the cost of beneficial-yet-costly therapies with the total cost of care. We cannot afford to overuse immuno-oncology agents, given their expense and potential for toxicity. Similarly, the potential to change the natural history of lethal cancers mandates that our patients have access to these drugs when appropriate. Yet, we can ill afford to pressure payers any further. In place of “breaking a back,” we need to reduce the total cost of cancer care by avoiding too much or too little care and applying care appropriately, which now clearly includes proper use of immuno-oncology drugs. Now more than ever, there is a need for implementation of value-based care delivery so that we never have to worry about a ording effective therapies for our patients battling cancer.