gms | German Medical Science

Objective: To analyze the prescription of protein kinase inhibitors (PKIs) for therapy of solid tumors in Saxony with a focus on translation of innovations to outpatient care. A downstream analysis further aims to determine off-label use, guideline concordance and drug survival of PKIs.

Background: PKIs are effective in the targeted treatment of various tumor entities. Since imatinib was the first to be introduced in 2001, several PKIs followed. In 2017, five new PKIs were approved for the german market. A main advantage to classic tumor treatment (e.g. chemotherapy) is the oral application of PKIs leading to reduced inpatient appointments and ambulance visits. Cancer treatment is being moved to the outpatient sector. However, the therapy is highly dependent on the patient’s adherence. Several studies showed a high correlation between deficient therapy adherence and poor therapy outcome. In addition, the physician plays an important role in terms of patient motivation and therapy support.

Methods: The analysis uses claims data from the health insurance company AOK PLUS in Saxony between 2010 and 2017 including 2.3 million insured persons. The data includes detailed information regarding diagnosis and drug prescriptions, physicians involved in the treatment, patient comorbidities and co-medication without documentation gaps.

At present, 36 different PKIs are approved for several tumor entities. In the present analysis, we focus on the following tumor entities due to high prevalence and guideline recommendations: renal cell carcinoma, colon carcinoma, melanoma, mamma carcinoma, bronchial carcinoma, prostate carcinoma, gastric adenocarcinoma, pancreatic cancer, liver cell carcinoma, urinary bladder carcinoma.

The analysis of guideline-concordant treatment is defined as the accordance of the medicinal therapy recommended in the guideline and the therapy in routine supply. In the example of renal cell cancer where several PKIs are recommended for therapy, guideline adherence is operationalized as follows: sunitinib or pazopanib are recommended as 1^st line therapy of advanced and/or metastasized renal cell carcinoma. A stationary diagnosis of renal cell carcinoma along with a diagnosed metastasis within the same inpatient stay without another cancer diagnosis is used as the definition of the advanced and/or metastasized renal cell carcinoma. In addition, procedures (OPS-codes) and drug therapy except PKIs (ATC-codes) are used for validation and operationalization of the guideline adherence of other tumor entities.

Drug survival is the analysis of the accordance of the prescription prevalence and the recommended therapy duration in the guideline. It will be operationalized via ATC-code/pharmaceutical registration number where information of package size and daily defined doses are used to calculate the therapy duration.

Prospect: The data analysis offers to evaluate the quality and guideline concordance of drug supply in oncology in Saxony and provides important indications for translation of innovations to outpatient care. Detailed information on the quality of drug supply of cancer patients in Germany is only available to a limited extent and has so far been lacking for many entities.

Keywords: oncology, Saxony, protein kinase inhibitors, claims data analysis