New Data On The Challenges Of Cost Effectiveness Modeling In Paediatric Use Marketing Authorisation (PUMA) HTA Submissions Presented 15TH Annual European Congress Of The International Society For Pharmacoeconomics And Outcomes Research (ISPOR)

New Data On The Challenges Of Cost Effectiveness Modeling In Paediatric Use Marketing Authorisation (PUMA) HTA Submissions Presented 15TH Annual European Congress Of The International Society For Pharmacoeconomics And Outcomes Research (ISPOR) PR Newswire BRUSSELS, Nov. 5, 2012 - Health Technology Assessment (HTA) Bodies may need to review their requirements when assessing products that have been granted a PUMA – - Buccolam® (Midazolam, Oromucosal Solution) was the first medicine to be granted a PUMA and has received positive recommendations by two HTA bodies in Europe - BRUSSELS, Nov. 5, 2012 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced the presentation of a poster on cost effectiveness considerations in submissions for therapeutics targeting small patient populations, including those considered under the new Paediatric Use Marketing Authorisation (PUMA) process. These data were presented at the 15th Annual Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), held November 3 - 7 in Berlin, Germany. The PUMA approval process differs from a traditional marketing authorisation, as it will often be based upon population subsets, as is often seen in orphan drug product development.