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Guidelines for Clinical Effectiveness Evaluation

Status: Published on
What are these Guidelines?

The clinical effectiveness of a technology is its ability to achieve a clinically significant impact on the health status of a patient. For example, the ability of a drug to reduce the risk of stroke by lowering blood pressure.

What is the purpose?

The purpose of the clinical effectiveness guidelines is to promote the production of Health Technologies Assessments (HTAs) that evaluate the impact of a technology on the health status of patients in accordance with best international practice. This in turn promotes the development of high quality HTAs that are relevant to the Irish healthcare system.

Who will use them?

The guidelines are intended to inform HTAs conducted by, or on behalf of the Health Information and Quality Authority, the Department of Health, the HSE and the National Centre for Pharmacoeconomics, to include health technology suppliers preparing applications for reimbursement. The guidelines are of relevance to those conducting HTAs elsewhere in the system and also as a reference source for those using HTAs to inform decision making.
The guidelines also have relevance for patient groups, the general public, clinicians, other healthcare providers, academic groups and the manufacturing industry.

How have they been developed?

These guidelines were developed by the HTA directorate in 2011 in consultation with the Authority’s HTA Scientific Advisory Group (SAG) and were updated in 2014. Following endorsement by the SAG, the draft Guidelines were made available for broader public consultation. The draft guidelines were revised as appropriate and were subsequently approved by the Board of the Authority before publication.
The draft documents that were made available during the public consultation process are also available - please contact or