The managed entry of new drugs into a national health service : a case study for Malta

Abstract

The research question was to determine if it is possible to develop a systematic approach to the managed entry of new drugs into a National Health Service( NHS), using Malta as a case study. In early 1999, Malta had major problems with the managed entry of new drugs into the NHS. Some essential processes such as medicines registration did not exist, and the processes that existed were not systematic. The policy for the introduction of new drugs resulted in a large number of non-formulary requests for individual patients, with such applications rising to 14,129 by 1998. There were no set criteria for assessing these applications and this together with internal and external influences led to inequity of access to drugs within the NHS. A case study was conducted. A descriptive evaluation was undertaken and a logic model was used to represent the case as in June 1999 (baseline). Areas for change were planned and prioritised. An action evaluation was undertaken and action research was implemented as an intervention for change. A second descriptive model was developed to represent the processes at the end of the action evaluation (December 2001). An outcome evaluation described the changes that took place during the action evaluation. A number of improvements supporting a more systematic approach were achieved. Several policies were revised and new policies developed where appropriate. The outcome was that new drugs were to be approved on the formulary for groups of patients (rather than individuals) that met specific criteria. Due to limited NHS resources inequity remains. However, the approach is now systematic which has made the processes more transparent. Recommendations for further development of the systematic approach were made with the aim of further reducing inequity.