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Policy Brief „How can the impact of health technology assessments be enhanced?“

Sorenson C, Drummond M, Kristensen F, Busse R
Copenhagen: WHO Regional Office for Europements be enhanced?“





Growth in the diffusion of new health technologies has led to remarkable improvements in health and quality of life. These benefits, however, also bring challenges in ensuring value for money and concerns over the willingness of third party payers and patients to pay for expensive treatments, devices and drugs. As policy-makers seek to obtain maximum benefit from limited resources, and do so in legitimate and transparent ways that reflect the values underpinning health systems, health technology assessment (HTA) is a tool increasingly used to support this aim and encourage the efficient use of health technologies (1,2).

Within the last 30 years, many European countries (European Union (EU) countries in particular) have established HTA programmes to inform a variety of decisions, from determining pricing and reimbursement to setting health service standards. Others, particularly smaller EU countries, are beginning to develop more informal programmes. The aim is to provide policy-makers and other key decision-makers with evidence-based information on the relative costs and benefits of available treatments, based on a systematic assessment process. This enables one to make decisions centred on value, by maximizing health for a given health budget for example, and gives patients and providers the information they require in making the best treatment choices. However, the way HTA is conducted and employed varies considerably, generating a number of issues surrounding its use in decision-making. This brief examines selected issues in the application and uptake of HTA in Europe. First, the impact of HTA can be affected by the bodies and takeholders involved in the assessment and appraisal process. National HTA bodies throughout Europe differ in their remit and responsibilities, but typically involve independent review bodies or entities under governmental mandate. This often affects their role in decision-making. The breadth of participation of key stakeholders, such as patients and providers, also plays an important role. While it can enhance the relevance, transparency and uptake of HTA, it may be resource and time intensive. The extent to which stakeholders are involved varies across countries, with few systems offering formal mechanisms for participation.

Second, along with its distinct scientific and policy objectives, HTA should be grounded in robust and transparent methods and processes, and be based on clear and standardized guidelines that outline evidence and methodological requirements. This is not always the case, and concerns remain over rocesses

for identifying and prioritizing topics for assessment, for providing the required evidence for review and data transferability, and for conducting assessments of high quality with rigorous methods. It is also important that HTA methods and Policy brief processes recognize the unique needs and circumstances of individual countries. This is especially true of smaller, low-capacity countries, which frequently lack the resources needed to develop and implement more formal and comprehensive assessments.

Third, the impact of HTA depends on effective and timely application in decision-making and subsequent implementation. The overall transparency of the HTA process and the extent to which the information generated meets decision-makers’ needs (for example, some require that broader social and ethical issues be considered while others do not) also influence the use of HTA. Successful implementation thus remains one of the least developed areas of HTA. With assessments and decisions typically made at national level, there are additional challenges in ensuring implementation at local level. For instance, national decisions or guidance may not be relevant to local circumstances and needs or coincide with available budgets and resources. This often results in uneven or delayed implementation. To address these issues, the governance of HTA could be improved in three key areas. First, it could be enhanced by involving a broad range of stakeholders throughout the HTA process, including setting priorities in the choice of topics for HTA, reviewing and interpreting evidence, and commenting on decisions. As decisions affect a variety of stakeholders, their perspectives should be captured to the extent possible. This will help provide decision-makers with the most relevant information, especially regarding ethical, social and organizational considerations. Several national European HTA bodies have mechanisms to address this.

Second, the methods and processes employed in HTA could be enhanced by improving their timeliness while maintaining high-quality assessments. Some countries, such as France and the United Kingdom, use simpler approaches and early warning programmes to provide more timely information on products deemed of policy, clinical or cost importance. Also, as is the case in the Netherlands and the United Kingdom, for example, decision-makers are increasingly using conditional approvals to manage the uncertainty surrounding new and emerging technologies. This allows for a technology to be fully reviewed and validated after additional, real-world data have been collected. Other approaches include formal and informal mechanisms for international collaboration across HTA bodies or programmes. This not only enhances transparency but also facilitates the transfer of knowledge and skills between countries, especially from more established HTA systems to lower-resource countries.

Finally, the impact of HTA on decision-making can be advanced with better implementation at local level. Measures include: targeted local communication of relevant decisions through either newsletters or expert ambassadors or networks; regulatory mandates for implementation; and formal or informal reevaluation (upon availability of additional data). While these strategies offer European governments opportunities for more informed decision-making, challenges remain. Some are specific to the HTA process itself, while others pertain to broader social and system-level considerations. The impact of HTA depends in large part on the quality and transparency of the assessment and decision-making process, in addition to the broader institutional, organizational, political and cultural dynamics of national health care systems. As many countries increasingly gear their health systems towards policies that emphasize measurement, accountability, transparency and evidence-based practices, the challenges of HTA should be addressed in order to achieve concurrent health system goals and support those services that offer greatest value for money and impact on health outcomes.

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