International Health Care Systems Pharmaceuticals Regulation

How long are delays in cancer drug approvals outside the U.S.?

Stereotypically, the U.S. health system is seen as one that is expensive and inefficient, but one where patients do get the fastest access to new innovation.  However, does that prove true in reality?  A paper by Zhang et al. (2017) attempts to answer this question by looking at 45 oncology drugs approved by the FDA between 2009 and 2013. I use these data to create the following chart measuring the share of drugs approved within different time frames after FDA approval.


Although most treatments are approved first in the U.S., in 1 out of every 15 cases (6.7%), approval happens outside the U.S. faster. Average time to approval is 10.6 months later in Europe, 14.9 months later in Canada, and 15.6 months later in Australia. Note that these figures may be underestimates because some of the treatments in the sample were not yet approved in which case I assumed that the approval date as one date after the end of the available data (December 31, 2013). If I just look at treatments approved by the FDA in 2009, 2010 or 2011, then the average delay increases to 12. months in Europe, and 24.1 months in Canada, and 23.2 months in Australia.

In short, if you live in Europe, you will have access to oncology treamtents 1 year after the U.S., but if you live in Canada or Australia, then it will be about 2 years before you get access to new oncology treatments.
Even if your drug is approved outside the U.S., it may or may not be the case that your insurance pays for it. The authors write:

Before December 31, 2013, 67% (30) of those 45 drug indications were approved by the EMA and therefore available (but possibly not covered) in the United Kingdom, and France approved all 30 EMA-approved drug indications. In Canada and Australia, 53% (24) of the drug indications were approved.
All these drug indications were covered by Medicare, with 23 covered in Medicare Part B and 22 covered in Medicare Part D.

In this case, the myth holds true. The U.S. health care system is more expensive but patients do have improved access to innovative medicines.


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