22 June 2011
Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe. Analysis by Friends of Cancer Research (FOCR) in Washington DC, US, indicates the median gap between a pharma company filing for approval for a new cancer medicine and the Food and Drug Administration (FDA) giving it the go-ahead was 182 days between 2003 and 2010. In Europe, the median time to gain European Medicines Agency (EMA) approval was 350 days.
This was not what the authors expected to find. 'We had heard a lot of criticism that the FDA was performing poorly compared to Europe in getting cancer medicines to patients,' explains Samantha Roberts, science policy analyst at FOCR. 'We started looking at the approval times to find ways to improve the FDA process, and what we found surprised us. It went against everything else we'd been hearing.'
The US approves cancer drugs almost twice as fast as Europe
© F. Hoffmann-La Roche
One reason for the US's faster approval times appears to be that cancer drugs are more likely to qualify for the FDA's priority and accelerated review systems. However, greater collaboration between the two agencies may address the difference in approval times. 'There seems to be a desire to make sure the policies around specific endpoints [of drug trials] are as similar as possible between the regulatory agencies,' says FOCR executive director Jeff Allen. 'I think there's an acknowledgement that it's not in anyone's interests to have a [pharma company] go through two extremely disjointed systems.'
The authors believe such initiatives will lead to the differences in approval times between the two agencies decreasing in future. It might also address whether a drug is approved or not - of the 35 drugs studied, 32 were approved in the US, compared to just 26 in Europe. The three the FDA turned down were all approved by the EMA.
Joshua Cohen, research assistant professor at Tufts Center for Drug Development in Boston, US, was less surprised. 'The results are consistent with several studies we've done recently,' he says. 'Cancer is an area in which the US still has a comparative advantage. Many products are biotechnologically derived and, generally speaking, biotechnology still does better in the US than Europe. Cancer advocacy is very powerful in the US, and there is still a lot of market upside in cancer therapeutics here, while many other therapeutic categories are saturated.'
Access over time
Cohen wishes access to cancer drugs was interpreted more broadly than simply looking at approvals, as well as taking into account the realities facing drug developers, patients, providers and payers today. 'Regulatory approval is half the battle, but it tells you little about real patient access to these drugs, and whether or not having access to certain drugs is even appropriate,' he says.
He thinks any discussion about cancer medicine availability must be done in the context of paying for them. 'In the US, we have a tiered system, and the patient's ability to pay out of pocket or buy good insurance plays an important role in determining access,' he says. 'Many do indeed have speedier and greater access to oncology drugs, but a significant group is not so lucky. In the US, some payers are explicitly and openly taking a closer look at all newly approved medicines, including cancer drugs... Nevertheless, in the US cancer remains a protected therapeutic class, especially for Medicare patients. In Europe, payers are definitely taking a harder line, in particular with expensive but marginally beneficial therapies.'
Cohen also believes lag times between approval and reimbursement decisions in Europe are shortening a little, and health technology agencies such as NICE should be praised for their honest and forthright approach to rationally allocating resources. 'They make mistakes, but at least they're mostly transparent about them,' he says. 'In the US, there is little transparency in the decision making process, and a lot of implicit rationing. We can no longer pretend we have unlimited resources. We don't. Hard decisions need to be made with a long-term view to benefiting society as a whole.'
Speed should not come at the expense of safety, however. According to Meg McArthur, senior policy and information officer at non-profit Breakthrough Breast Cancer, it is difficult to directly compare the FDA and the EMA and the processes they use as they are required to adhere to different laws and regulations. 'Patient safety is of the utmost importance,' she stresses. 'Therefore, it is necessary that the appropriate measures and time required are taken to ensure approvals for new drugs are safe.'
Allen also says it is important that financial resources are available to support rigorous review. 'During this time of increasingly difficult budget environments, we have advocated that US Congress provides the resources necessary to support rigorous review at the FDA,' he says. 'This isn't to say that the current system is perfect - but it's worth examining ways in which it could be improved.'