The new drug landscape is unimpressive in large part because many older meds have been shown to be just as strong as new entrants.
That’s one takeaway of a study, published in Health Affairs. Researchers Mark Olfson and Steven Marcus dug into placebo-controlled trials published by four journals between 1966 and 2010 and found a significant decline in the impact new drugs are having compared to placebos. Although they suggested that the move to larger clinical trials over the 44 year period could dilute the reported results in latter-day trials, larger population sizes are not enough to account for the difference. They note that even looking at the 2001-2010 span, which would compare large trials to large trials, results still showed that drug versus placebo trials showed very little difference in efficacy.
This is not necessarily a revelation, in the sense that fear of the patent cliff was as much about lost exclusivity as well as the concern that there was nothing to fill the hole for the same categories because the medications were so effective. What’s new is that the researchers confirm what advertising agencies and ACOs have been telling the pharmaceutical industry for some time: that a brand name is not a benefit. Real-life impact — as in dollars saved over the long term, tolerability, and, if offered, support for patients and doctors — does.
In this situation, researchers recommend establishing equivalence in efficacy and putting the effort behind “focusing on differences in cost, safety and tolerability.” The add-on to this is the work drug makers have been rolling out, such as patient support programs. Slim biosimilars margins also provide a point of reference: although the US has yet to draw up final guidelines, the marketing needs are not unknown. Sandoz told MM&M in an earlier interview that a painful financial lesson in the biosimilars space was that the sales pitch has to include the overall scope of support if a drug is going to make a dent in the market. The overlap is not hard to find, particularly as Olfson and Marcus note that even generics makers are suffering from a patent cliff of its own, since the market is saturated with effective drugs.
