SAFETY AND INSURANCE PREMIUM IMPLICATIONS FOR HOSPITALS BASED ON SUBCUTANEOUS VERSUS INTRAVENOUS ADMINISTRATION OF ONCOLOGY / HEMATOLOGY THERAPIES- CASE STUDIES WITH RITUXIMAB (MABTHERA) AND TRASTUZUMAB (HERCEPTIN)
Author(s)
Walzer S1, Era S2, Profico A2, Canciani M3, Farina M3, Ponzetti C4
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2Roche Spa, Monza (MB), Italy, 3EmmEffe S.r.l. Management & Formazione, Milano, Italy, 4Sanitario Gruppo Policlinico di Monza, Montalto Dora, Italy
OBJECTIVES: In oncology an important parameter of safety is the potential treatment error in hospitals. The hypothesis which is being analyzed in the underlying work is the potential benefit of hospitals from a safety reduction through fix-dose ready to use subcutaneous therapies in comparison to intravenous therapies with trastuzumab and rituximab. METHODS: For the calculation of risk levels the Failure Mode and Effect Analysis (FMEA) approach was being applied. Within that approach the critical treatment path is followed and risk classification for each individual step is being estimated. For the oncology and hematology administration there were 35 different risk steps assessed. The study was executed in 17 hematology and 16 breast cancer centers in Italy. CONCLUSIONS: The use of a subcutaneous administration of trastuzumab (breast cancer) and rituximab (hematology) might lower the risk of administration and treatment errors for patients and could hence indirectly have a positive financial impact for hospitals.
RESULTS: When the risk classes are calculated there were eight high risk areas identified for the administration of an intravenous therapy in hematology or oncology, 13 areas would be defined as having a median risk and 14 areas as having a low risk classification (total risk areas: n=35). When the new subcutaneous formulation would be applied 23 different risk levels could be completely eliminated (65% reduction). Including those eliminations important high risk classes such as the following were included: dose calculation, preparation and package labeling, preparation of the access to the vene and pump infusion preparation and infusion monitoring. The overall risk level for the intravenous administration was estimated to be 756 (ex-ante) and could be significantly reduced by 70% (ex-post). The potential harm compensation for errors related to the pharmacy would be decreased from 234’271 € for eight risk classes to only 3 risk classes.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PCN60
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Oncology, Systemic Disorders/Conditions