UNCERTAINTY REGARDING NICE'S END-OF-LIFE SMALL PATIENT POPULATION CRITERIA
Author(s)
Moïse P1, Sweeney N2, Holmstrom S31Quintiles Global Consulting, Levallois-Perret, Ile-de-France, France, 2Quintiles, Hoofddorp, Netherlands, 3Astellas Pharma Global Development, Leiderdorp, Netherlands
OBJECTIVES: Evaluate how NICE applies the small patient population criterion (EOL-SPP) of its End-of-Life (EOL) supplemental advice and confirm whether or not it applies this criterion to currently licensed indications only. METHODS: NICE’s website was searched for cancer drug single technology assessments (STA) from January 2009 to May 2012. Only those assessments where EOL considerations applied were selected for further evaluation. Each STA was evaluated on how NICE used the EOL-SPP criterion. RESULTS: We identified 25 STAs for which EOL advice was given for 29 anti-cancer agents, including guidance on one final appraisal determination. 22 drugs met NICE’s EOL-SPP for the indication for which they were being appraised. Twelve of these drugs had the EOL-SPP criterion applied to the only indication for which they were licensed. The EOL-SPP criterion was applied to the cumulative populations of ten drugs which had marketing authorization for more than one indication. The seven drugs that did not meet the EOL-SPP criterion all had individual indications which were within the number of what is considered acceptable (≤7,000), but had total cumulative populations that were greater. Two STAs in particular stand out. The appraisal committee accepted that panitumumab met the EOL-SPP criterion for its current indication but noted that the EMA recommended a marketing extension which would raise the expected patient population to 10,000. In its final appraisal determination for abiraterone NICE overturned its original decision that the drug did not meet the EOL-SPP criterion, even though it noted that abiraterone may be recommended for a marketing extension for a greater patient population. CONCLUSIONS: There is no evidence to suggest NICE applies the EOL-SPP to the cumulative populations of currently licensed indications plus potential future indications.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PCN149
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology