CHALLENGES IN THE DATA COLLECTION REGARDING PATIENT POPULATION AND TREATMENT COSTS FOR NON-DRUG INTERVENTIONS USING THE EXAMPLE OF MORBUS DUPUYTREN

Author(s)

Kürschner N, Schiffner-Rohe JPfizer Deutschland GmbH, Berlin, Germany

OBJECTIVES: Since 2011, pharmaceutical companies have to submit a benefit assessment dossier for new drugs in Germany. The dossier must contain information about the additional benefit to an appropriate comparative therapy (ACT), costs and the potentially targeted patient population. This work’s aim is to display the challenges in collecting the information for Xiapex®, approved for treatment of Dupuytren’s contracture in patients with a palpable cord, which was compared to limited fasciectomy. METHODS: A systematic literature review, national and international, was used to determine epidemiological figures and cost data. Where no information was available, necessary data was assessed from claim data. To determine the percentage of patients with palpable cord a Delphi study was conducted with office based hand surgeons and orthopaedists. RESULTS: No valid data basis was found for national epidemiological figures. Estimations based on European prevalence data (1,7%-2,4%) lead to 1,34-1,9 Mio. Germans affected by Mb. Dupuytren. Thereof, approx. 35.800 surgeries are conducted in Germany per year. The Delphi-study revealed an estimation of 53,5% patients with palpable cord, resulting in 19.153 patients eligible to Xiapex® treatment. No literature was found for treatment costs of Mb. Dupuytren. Actual costs (inpatient and outpatient care plus additional costs) were therefore selected from available claim data resulting in a weighted average of 2087,58€  per patient and year. CONCLUSIONS: With a surgical procedure as ACT, dossier developers have to face challenges due to the lack of transparent, publically available data. Best available sources were used to gather the information needed. The fact that the German IQWiG challenged our data within the benefit assessment process without being able to provide better sources of information underlines the necessity of an improvement regarding the availability and open access to suitable data. This will increase validity of data in the required dossier for an informed consequent decision making.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP140

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Multiple Diseases

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