Reappraisal Following the Loss of Medicine Patent in HTA Guidelines

OBJECTIVES: We aimed to explore whether a proactive approach should be used to update HTA guidance when: (i) A medicine that had originally received a negative recommendation becomes unbranded (and has a lower price), (ii) An original medicine was not appraised but is now off patent, and (iii) A comparator treatment in an original appraisal is now unbranded.

METHODS: We undertook a review of existing National Institute for Health and Care Excellence (NICE) appraisals to explore the practical implications of using existing evidence from previous appraisals to assess whether, and how, this type of information could be repurposed to facilitate a rapid assessment of unbranded technologies. We also undertook a detailed assessment of seven appraisals where an intervention within the pathway had since become unbranded.

RESULTS: Of 74 appraisals that had originally received a negative recommendation, 8 of the originator drugs were later recommended because of later appraisals, and 60 led to changed guidance. In 6 cases, recommendations stood, despite the medicine becoming unbranded. Of the 7 detailed assessments, in 6 cases we found that a rapid re-assessment would not possible because: (i) The pathway had changed, (ii) The clinical effectiveness evidence for the originator was considered poor, or (iii) The model had been deemed unreliable due to structural flaws, implausible assumptions or errors that the ERG had not been able to rectify. Only the documentation from 1 of these STAs had the potential to be repurposed to inform a rapid assessment of an unbranded version of the originator.

CONCLUSIONS: In most cases, current approaches to HTA were able to deal with losses of patent, due to the regular appraisal of disease areas when new medicines reach market. In only a small proportion of cases would a proactive approach (i.e. at the point a medicine loses its patent) be useful.