Health Technology Assessment (HTA)

Once a drug has been through the MHRA process and receives a marketing licence, it can be prescribed for use. However, in the UK, the drug only becomes routinely available on the NHS when it has been approved by one of the national Health Technology Assessment (HTA) bodies. Until this has been done, permission usually has to be sought from the local health body to use it on a one-off basis.

HTA is a multidisciplinary activity that systematically evaluates the safety, clinical efficacy and effectiveness, cost, cost-effectiveness, organisational implication, social consequences and legal and ethical considerations of a health technology i.e. a drug, medical device or procedure.

In the UK, in the context of a new drug, HTA broadly focuses on two things:

• Clinical effectiveness – how the health outcomes of the drug compare with available drugs
• Cost effectiveness – whether the improvements in health outcomes are commensurate with the additional costs of the drug

The purpose of HTA bodies is to help ensure that the NHS provides clinically- and cost-effective drugs. They acts as a “bridge” between evidence and policy-making and seeks to provide health policy-makers with accessible, useable and evidence-based information to guide their decisions about the appropriate use of the drug and the subsequent efficient allocation of resources.

There are currently three HTA bodies in the UK:

• National Institute for Health and Care Excellence (NICE) which makes assessments on behalf of the NHS in England and Wales
• Scottish Medicines Consortium (SMC) which undertakes HTA for NHS Scotland
• All Wales Medicines Strategy Group (AWMSG) which produces guidance on treatments on the NHS Wales to cover the gap before NICE guidance becomes available

Each HTA is appraised by the appropriate body which issues guidance on how the drug should be used. If a drug does not appear to offer good value for money, it may not be approved for use within the NHS even if it is clinically effective. There is no specific HTA body in Northern Ireland and approval is generally based on NICE guidance.

Nurses should be aware that HTA has been an important component of health policy in the UK for many years. Despite the questions and controversies around individual decisions and the process in general, HTA will continue to play a key role in assessing the value of new drugs and informing decisions about which drugs should be made available on the NHS. There are alternative funding schemes for cancer treatments that allow access to the most promising new treatments prior to full HTA approval, such as the Cancer Drugs Fund in England and Wales, the New Medicines Fund in Scotland and individual funding requests for a small number of special circumstances.

For more information on HTA, read out Clinical Trials Infoguide.