Table 1 Examples of positive and negative comments by the ERGs and appraisal committees

Positive Comments

• “the General Practice Research Database data presented by the manufacturer have advantages over the [published] study in that they are more recent and therefore more reflective of the current UK atrial fibrillation population”

• “annual mortality rates from the general UK population, adjusted for the increased risk of death in patients with moderate to severe psoriasis relative to matched controls based on the UK GPRD study … … the committee concluded that the company’s approach to modelling mortality reflected the best available evidence.”

• “GPRD data were used as they may be more representative of the UK patient population than data from clinical trials. Use of GPRD data is also consistent with sources preferred in the NICE appraisals of ….”

Negative comments

• “The Committee was made aware of [CPRD] data indicating that acid-suppressive medication leads to a small increase in fracture risk …. The Committee was not persuaded by this evidence; it noted that the data are observational and have not been reported in full ….”

• “… the ERG was concerned with the appropriateness of using CPRD data to estimate the resource use for the patient profiles observed in the trial because there were differences in the 2 populations.”