Off-label use of anticancer medications

It’s ASCO abstract season, which means a return to reality from holidays with family and friends — and a few sleepless nights before the January 6th deadline for electronic submission. I was going to have coffee at a Starbucks in Raleigh last night but work, of course, came first and I spent the evening with my computer instead.

The coffee meeting would have been a little out of the ordinary. On a whim, as a health policy hobbyist and a participating U.S. citizen, I checked “yes” to become an American College of Physicians “key contact.” I was interested in a back door to policy discussions as much as the chance to help advocate for internists (for a link to the ACP advocate blog, click here: http://blogs.acponline.org/advocacy/). Within a few weeks of signing up, I received an invitation to this coffee meeting — organized by local physicians, under the auspices of the presidential transition team, where I could talk about policy issues that mattered to me.

So, nevertheless, I couldn’t make it — but this did serve as a reminder for me to keep up with policy developments, so that if I did go to one of these coffees in the future, I would have something to say.

Here’s something that I suspect will become more important in the months ahead: the growing off-label use of anticancer drugs. I was stimulated to think about this by a recent article I came across in Lancet Oncology on this topic, which then led me to review this ASCO policy statement from 2006, published in the JCO. Here’s the short version of the issue: in 2005, the total cost of cancer care in the United States was $209.9 billion (see this link for a discussion in JCO of the cost of cancer care: http://www.jco.ascopubs.org/cgi/content/abstract/25/2/180) and continues to grow year by year. Oncology drugs account for about 40% of all Medicare drug spending. Recent evidence indicates that off-label use of anticancer drugs has increased to at least 50% of anticancer drug prescribing by NCCN estimates, and probably northwards of that. Certainly much of this prescribing is appropriate and in fact vital to allow patients access to up-to-date cancer treatments that have become standard of care. Medicare relies on several compendia for coverage determinations of off-label use, with varying degrees of supporting evidence. But is all of this prescribing appropriate? What is, and what isn’t? A new report from McKinsey looks at why we spend more on health care in the United States and finds that part (though not all) of the story relates to the adoption of and spending on new and expensive drugs. For better or worse, as policymakers look to save money, I suspect that off-label prescribing of anticancer drugs will be a topic of considerable interest and study in the months and years ahead.