PP023 Applying Oncology Patient Registries As A Health Technology Assessment Tool

Abstract

INTRODUCTION:

The limited healthcare resources have to be invested efficiently; Health Technology Assessment (HTA) is applied ever more often in many health care systems for “rational decision-making”. The oncology patient registries (OPR) track the eligibility of patients and the complete flow of treatments, guaranteeing appropriateness in use of pharmaceutical products, according to approved indications.

METHODS:

Normative legal acts and other regulatory documents in the field of oncology medical and pharmaceutical activity, include content and maintenance oncology registries. The system, process and information analysis, direct observation, comparative analysis, logical modelling, sociological methods (surveys and expert opinions) are applied.

RESULTS:

A temporary coverage/funding of oncology drugs often requires additional collection of data on safety, effectiveness, cost-effectiveness, and the appropriate use of the drug. Many of the oncology drugs show little or marginal effectiveness at time of approval and reimbursement agencies demand further data before deciding whether to cover the new drug. Pragmatic clinical trials, patient access schemes and standard data requirements on patient relevant outcomes in OPR are some of the approaches to generate further evidence and to fill the gap between knowledge on efficacy at time of approval and demanded knowledge on effectiveness for coverage decisions. For each monitored drug, patients eligible for treatment are registered in the specific therapeutic indication dynamic monitoring database to collect epidemiologic and clinical data, including data on the safety profile, and ex-post information missing at first evaluation stage.

CONCLUSIONS:

OPR provide a detailed view of the morbidity, mortality and resource utilization associated with an oncologies diseases entity. This data is of prime importance in coming to decisions on coverage of a drug or treatment. The collation of information is also quick and efficient owing to better methods of data management. OPR of Kazakhstan are equipped with sophisticated data processing software and technologies.