We’ve all heard it before, and it’s a mantra to any parent or teacher, "If you don’t succeed, try, try again." But when it comes to drug development, how persistent are companies when seeking a positive reimbursement decision if their first submission has been rejected? Much like regulatory approval, reimbursement decisions often require multiple submissions before getting a positive outcome. We thought it would be interesting to look at the data on submissions to get a better idea of what’s really happening.
At the recent ISPOR European Congress in Dublin, we presented an analysis of 425 reviews from three Health Technology Agencies (HTAs); Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the Scottish Medicines Consortium (SMC). These agencies were chosen for our study because they make reimbursement decisions AND accept resubmissions.
The reviews cover 23 disease conditions and were published from 2005 to September 2013 across three countries; this time period was long enough to allow for resubmissions. Of these reviews, 334 were initial submissions and 91 were resubmissions. The majority of these reviews resulted in a positive decision upon first submission (66%, or 219 reviews). But for those that did not, we found it interesting that 62% (71 out of 115 reviews) were never resubmitted. Click here to see the full poster presentation.
The Magic Number?
The charts above show some other interesting numbers:
- It took an average of 1.39 submissions to achieve a positive decision from PBAC. This was higher than both CADTH (average of 1.17) and SMC (average of 1.16). The difference between PBAC and SMC was statistically significant at 5%
- PBAC’S review times ranged from 29 days (fastest) to 3,775 days (slowest)
- CADTH’s review times ranged from 672 days to 1,248 days
- SMC’S review times ranged from 120 days to 1,857 days, although the longest two SMC reviews were outliers for the sample
As seen in the chart above, at 898 days CADTH's median time to positive decision was longer than that of either PBAC (365 days) or SMC (304 days). At 1,090 days, PBAC had the longest mean time to positive decision, and there were no outliers in the PBAC sample. Roughly 1/3 of the PBAC reviews took more than 1,000 days to achieve positive decision. The analysis had a small sample size: 24 PBAC reviews, 6 CADTH reviews, and 16 SMC reviews.
Try, Try Again…
What’s interesting is that after spending so much time and effort developing these compounds, 62% of the HTAs that were rejected on the first submission never resubmitted.
Then there are the differences between the agencies. CADTH had the largest percentage of reviews that were never resubmitted. This may be explained because reimbursement can be achieved from the provincial governments in Canada instead of the national government, so resubmission may not be necessary.
PBAC required a greater number of submissions to gain a positive decision, and the average lag time to a positive decision was longer as compared to SMC and CADTH. The number of submissions needed for CADTH and SMC were similar, but CADTH’s median lag time was twice as long as SMC’s.
Did You Follow All That?
It can get very complex very fast, we know… and without a systematic way to track the reviews and spot these types of patterns, it can be overwhelming. Could it be that keeping up with all of the moving parts is one reason that companies are choosing not to resubmit?
And if that’s the case, are the pharmaceutical companies leaving money on the table while we the public miss out on potentially important new drugs?