United Kingdom -- RTI Health Solutions (RTI-HS) provided the first cost-utility model and appraisal dossier to be submitted to the UK National Institute for Health and Clinical Excellence (NICE) under their new, rapid process for assessing drugs, the Single Technology Appraisal (STA) process.
Announced in November, 2005, the STA process is intended to produce faster guidance on new medicines and life-saving drugs. As part of the first STA submission, RTI-HS provided a sophisticated, probabilistic, cost-utility model demonstrating the cost-effectiveness of an oncology drug. Additionally, RTI-HS compiled a full dossier using the new, more demanding STA dossier format. The dossier contained all of the relevant clinical and pharmacoeconomic evidence for the drug.
The STA route presents manufacturers with new opportunities and challenges. The STA process will take approximately six months to complete, in comparison to approximately fourteen months for the existing, “multiple technology appraisal” (MTA), process. This expedited process is a single technology appraisal in which the new intervention is compared with current practice only, and not with other new interventions. The STA differs from the MTA in the level of detail specified for the submission, the mandatory submission of models, and arrangements for feedback on draft guidance. Thus a NICE recommendation is expected many months earlier.
For more information contact Sorrel Wolowacz
or call 44.(0)161.232.3400