“BEST SUPPORTIVE CARE” OR “THERAPY ACCORDING TO PHYSICIAN'S CHOICE” AS APPROPRIATE COMPARATOR FOR GERMAN HTA DOSSIERS – AN UNDERESTIMATED CHANCE OR RISK FOR THE BENEFIT ASSESSMENT?
Author(s)
Eheberg D1, Dannemann S2, Jakovac M3, Bonduelle D1
1IMS Health, Munich, Germany, 2QuintilesIMS, Munich, Germany, Munich, Germany, 3IMS Health Germany, Munich, Germany
BACKGROUND: The choice of the appropriate comparator is a central aspect of the German HTA dossier. In most cases the appropriate comparator, which is defined by four criteria set in the rules of procedure of the federal joint committee (G-BA), is a list of equally appropriate substances and treatment methods. However, in some cases the G-BA deviates from this approach and determines that either “best supportive care” (BSC) or “therapy according to physician’s choice” (TPC) is the appropriate comparator. OBJECTIVES: The aim of our project was to assess how often BSC and TPC were used as an appropriate comparator and to evaluate the consequences in benefit for the submitted dossier. Additionally, we wanted to evaluate what triggered the choice. METHODS: We reviewed the decisions published on the G-BA website between 01.01.2011 and 01.06.2016. The submitted dossiers were screened for appropriate comparators referring to BSC or TPC and a descriptive analysis was performed to identify a decision algorithm. RESULTS: We identified 12 substances with 18 subpopulations with BSC as appropriate comparator and 13 substances with 15 subpopulations with TPC. The main reason to determine BSC as appropriate comparator was a lack of alternatives, mostly in the context of palliative indications. For TPC unclear guidelines and uncertain evidence was a key criterion. An additional benefit was granted in nearly half of the subpopulations with BSC as appropriate comparator. For TPC only in four subpopulations an additional benefit was determined. CONCLUSIONS: TPC and BSC offer an opportunity for substances without direct comparison trials. Especially BSC is the best way to present data from placebo-controlled trials. In the last years the number of benefit assessments for substances with TPC as the appropriate comparator has increased. TPC is more challenging than BSC and it is hard to fulfill the elaborated standards of G-BA and IQWiG.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP309
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Decision & Deliberative Processes
Disease
Multiple Diseases