NICE accepted the highest proportion of submissions with ICERs higher than the threshold out of all the HTA agencies.
NICE recommended the highest proportion of submissions with ICERs higher than the threshold (34% accepted without restrictions; 20% with restrictions), followed by PBAC (16% accepted without restrictions; 4% with restrictions), SMC (11% accepted without restrictions; 14% accepted with restrictions), and CADTH (0% accepted without restrictions; 26% with restrictions).
19 The results of our research support the theory that orphan drugs may have higher WTP thresholds, as several submissions with higher-than-threshold ICERs were accepted on the basis of meeting orphan drug criteria.
CADTH did not unconditionally accept any submissions with ICERs higher than the threshold, instead placing restrictions on all such submissions that gained a positive reimbursement decision.
The acceptance of submissions with ICERs higher than the threshold was assessed across different agencies and across indications, in order to inform future reimbursement submissions.
As for NICE, malignant disease and immunosuppression accounted for the majority of SMC submissions overall as well as submissions with ICERs higher than the £30,000 cost-effectiveness threshold.
21 The acceptance rate for SMC was lower than for NICE, both overall and for submissions with ICERs higher than the threshold.
We hypothesized that no significant differences in acceptance rates of submissions with ICERs higher than the threshold are observed between disease areas.
We found that, overall, over a quarter of submissions with ICERs higher than the threshold were given a positive reimbursement submission; however, 42% of these submissions were restricted in their use within the relevant health system.
Across all agencies, acceptance rates were statistically significantly lower for submissions with ICERs higher than the threshold than for submissions with ICERs lower than the threshold (P<0.0005 for all agencies).
Following the trend for NICE and SMC, the majority of PBAC submissions (overall as well as submissions with ICERs higher than the AUS$42,000 cost-effectiveness threshold) fell into the malignant disease and immunosuppression category.
