| 1. |
- Wettermark, B., et al.
(författare)
-
Soft regulations in pharmaceutical policy making : An overview of current approaches and their consequences
- 2009
-
Ingår i: Applied Health Economics and Health Policy. - 1175-5652 .- 1179-1896. ; 7:3, s. 137-147
-
Tidskriftsartikel (refereegranskat)abstract
- It is a challenge to improve public health within limited resources. Pharmaceutical policy making is a greater challenge due to conflicting interests between key stakeholder groups. This paper reviews current and future strategies to help improve the quality and efficiency of care, with special emphasis on demand-side controls for pharmaceutical prescribing. A large number of different educational, organizational, financial and regulatory strategies have been applied in pharmaceutical policy making. However, the effectiveness of most strategies has not been thoroughly evaluated and there is evidence that the behaviour of healthcare professionals is difficult to influence with traditional methods. During the last decades, new modes of governing and new governing constellations have also appeared in healthcare. However, relationships between those who regulate and those regulated are often unclear. New approaches have recently been introduced, including extensive dissemination strategies for guidelines and extensive quality assessment programmes where physicians' performances are measured against agreed standards or against each other. The main components of these 'soft regulations' are standardization, monitoring and agenda setting. However, the impact of these new modes on health provision and overall costs is often unknown, and the increased focus on monitoring may result in a higher conformity and uniformity that may not always benefit all key stakeholders. Alongside this, a substantial growth of auditing associations controlling a diminishing minority of people actually performing the tasks may be costly and counter-productive. As a result, new effective strategies are urgently needed to help maintain comprehensive healthcare without prohibitively raising taxes or insurance premiums. This is especially important where countries are faced with extreme financial problems. Healthcare researchers may benefit from researching other areas of society. However, any potential strategies initiated must be adequately researched, debated and evaluated to enhance implementation. We hope this opinion paper is the first step in the process to develop and implement new demand-side initiatives building on existing 'soft regulations'.
|
|
| 2. |
- Björnerstedt, Jonas, et al.
(författare)
-
Validation of overall survival extrapolations made by TLV in the assessment of cost-effectiveness of oncology drugs in Sweden : A pilot study comparing extrapolated and observed life-years gained
- 2024
-
Ingår i: Journal of Medical Economics. - : Taylor & Francis. - 1369-6998 .- 1941-837X. ; 27:1, s. 193-200
-
Tidskriftsartikel (refereegranskat)abstract
- Aim: The aim of the study is to assess the accuracy of overall survival (OS) extrapolations in cost-effectiveness analysis made by the Dental and Pharmaceutical Benefits Agency (TLV) to decide on the reimbursement and use of oncology drugs in Sweden.Material and methods: TLV appraisals for oncology drugs were identified during a 5-year period (2013-2017). To be included each appraisal and health economic model must include a TLV base case extrapolation of OS. Further, Kaplan-Meier (KM) estimates on OS from the original and follow-up clinical trials must be available. Potential follow-up trials on OS were identified in ClinicalTrials.gov and the Lund University Libraries databases, and in the Swedish Medical Products Agency (MPA) and the European Medicines Agency (EMA) databases. In cases where the KM estimates were not available, data points from figures published in TLV's appraisals were extracted using the semi-automated tools Digitizelt and WebPlotDigitizer. The accuracy of survival extrapolations was assessed by comparing extrapolated and observed life-years (LYs), using three different measures: 1) difference in LYs between the treatment and control group; 2) LYs in the treatment group, 3) LYs in the control group.Results: We study TLV's preferred OS extrapolations and show that on average they overestimate the observed mean gain in LYs by 17%, and underestimate observed LYs by 5% and 1% in the treatment and control group, respectively.Conclusions: We conclude that it is feasible to validate OS extrapolations by comparing extrapolated and observed life-years. Even if survival extrapolations are reasonably accurate for the treatment and control group, respectively, this may still imply that extrapolations of LYs gained deviates to a larger extent. Follow-up studies on OS should be carried out to an increased extent to be able to validate, update and improve OS extrapolations in cost-effectiveness analysis of oncology drugs.
|
|
