Physicians are increasingly advocating a patient-centered approach to practicing medicine, and both regulatory agencies and manufacturers also seem to agree that patient reported outcomes (PROs) are valuable. Considering this increasing industry-wide interest, you would expect that PROs are increasingly being used across various aspects of drug development - in clinical trials, regulatory reviews, and reimbursement assessments. At the 17th Annual International Meeting of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) we presented the results of research examining the use of PROs in HTAs. That study examined 324 reviews published by nine agencies from 2005-2011 for 13 disease conditions.
We thought it would be interesting to revisit this question as our application now has many more reviews available for analysis than in 2012. For the updated analysis, we examined 1,567 reviews. This allowed us to compare the behavior of 12 regulatory agencies worldwide from 2005 to 2012 across 44 disease conditions. Of these reviews 1,394 allowed us to determine definitively whether or not they used PROs. In our update, we restricted consideration to this set of reviews.
Our results were generally consistent with our earlier findings.
- Patient reported outcomes were used in 51% of HTAs from 2005 through 2012. They were not used in 49% of HTAs
- Ten of the agencies compared used PROs in more than 50% of their reviews. Three agencies used PROs in more than 80% of their reviews
- Over the eight recent years we examined, there’s no clear trend in PRO use over time. Specifically, the use of PROs in HTAs does not seem to be increasing
- PROs were used more often in HTAs that resulted in a decision of “Recommend” (62%) than in those resulting in a decision of “Do not recommend” (48%)
Clearly it’s taking some time for the industry to catch up to what it says it wants to do. It will be interesting to revisit this story again next year to see if 2013 begins to show an upward trend in the use of PROs.