Off-Label Use of Anticancer Therapies: Physician Prescribing Trends and the Impact of Payer Coverage Policy

The issues raised in this study of off-label use of cancer medicines and the impact of coverage policy represent a challenge to all of us who treat patients with cancer.

Oncologists have always recognized the importance of practicing evidence-based medicine in caring for patients, and the specialty has been at the forefront of research to develop that evidence since its inception. We live now in exciting times of rapidly advancing technology that can dramatically improve the length and quality of life for our patients.

These rapid advances often outstrip the traditional ways of disseminating that information through publications in journals. The question is not the value of evidence-based medicine, but what constitutes adequate evidence and who should be the judge of its value.

Most oncologists in practice are aware of new information of value to their patients as soon as it is disseminated. Yet, many clinicians in private practice feel they cannot offer these innovative new treatments because of the uncertainty of reimbursement. Reimbursement rules are unclear at best, and there are extremely long delays in payment, even when claims are successful.

Extra office personnel time is needed to fight these battles, and resources are shrinking as reimbursement for services shrinks. Unfortunately, many oncologists, in the end, feel it is easier and less risky to avoid offering these new therapies than to jump through the many hoops required to recover money already spent on the drug in question. 

The issues raised in this document are very real. Both providers and policy makers must collectively address the profound effect the red-tape hassle can have on the practice of oncology and, more importantly, on patient access to the newest treatments available.