File this under the 'big trade off.' Between 2000 and 2011, new oncology drug approvals in the US outpaced European approvals by 33 percent. But at the same time, prices for cancer medications in Europe, on average, were 9 percent lower than in the US, according to a new report from the Tufts Center for the Study of Drug Development, which attempted to gauge how comparative effectiveness research influences the use of pharmaceuticals in providing care.
When it comes to cost, Tufts noted patient cost sharing is much lower in Europe than in the US, where the average co-insurance rate per covered drug was 33 percent, suggesting "US patients are responsible for co-payments of hundreds to thousands of dollars per prescription or treatment cycle," Tufts writes. For example, insurance coverage ranged from 46 percent in the UK to 98 percent in the US, although this did not take into account patient assistance programs.
On the other hand, Europe imposes more delays on reimbursement. Why? Marketing approval granted by the European Medicines Agency lags behind the FDA, and European reimbursement is further compounded by delays between EMA approvals and reimbursement decisions. In fact, it can take up to one year following regulatory approval for a reimbursement authority to make a reimbursement decision.
A few comnparisons: Between 2000 and 2011, the FDA approved 40 cancer meds, and of the 28 drugs approved by both the FDA and the EMA, all were approved first by the FDA. But approval times, in some cases, lagged considerably. The Gleevec med sold by Novartis was approved eight months later in Europe, for instance. Of course, drugmakers often target the US market before Europe, since reimbursement decisions are also speedier.
"While greater access to more treatment options is definitely a positive for patients in the U.S., it is not clear if greater access leads to better health outcomes," Joshua Cohen, a research assistant professor at Tufts CSDD, who conducted the analysis, says in a statement. However, Tufts believes that comparative effectiveness research, which is gaining ground in the US, may help close the gap between between what is known and what is done in pharmaceutical care.
"On one hand, use of comparative effectiveness research by reimbursement authorities in health care systems outside the US may restrict access to drugs deemed not clinically- and cost-effective. For example, comparative effectiveness research informs reimbursement decisions on cancer drugs by European authorities," Tufts writes. "On the other hand, comparative effectiveness research creates conditions for a more affordable and equitable system of access."
"Although more oncology drugs are available in the US and the costs for a higher share of them are reimbursed, the evidence-based approach adopted by European systems together with each system’s monopsony power have led to lower prices, improving the affordability of drugs considered cost-effective by the reimbursement authorities," Tufts concludes. Monopsony, by the way, refers to a market in which one buyer, not seller, controls much of the market.
As for pricing, here are a few examples: the average sales price (plus 6 percent) for the Vectibix colon cancer treatment was $3,660 in the US, and $2,535, on average, in Europe. The US price for Erbitux was $1,060, while it cost $446 in Europe. The lower prices in Europe, Tufts writes, may reflect price controls and a single buyer pricing system (here is the Tufts release).
pill pic thx to anolobb on flickr