HTA is one of the final steps that pharmaceutical companies must undergo before their medicines can be marketed in Europe. It is a vital step for market access and can be costly and time-consuming.
The European Commission recently rolled out a new regulation to harmonise HTA cooperation across Europe. This will benefit patients and providers by reducing duplication of work and accelerating medicines access.
What is an HTA?
An HTA is a structured process used to assess the clinical and economic evidence surrounding the use of new health technologies. This process ensures that new technologies are added only after proven effectiveness and cost-effectiveness have been shown. This is important for reducing the risk of adding or removing unproven technologies that may increase health costs.
The European HTA process consists of two main components – assessment and appraisal (see Figure 2 for a description of these processes). In an assessment, evidence is assembled to evaluate the clinical and economic impact of a technology. The appraisal phase uses the evidence gathered during the assessment to make recommendations about how a new technology should be covered by a health system or payer.
As the global pharmaceutical industry continues to develop new products, there is a need for increased understanding of how these products can benefit patients and what the appropriate pricing should be for these products. This is an area that is rapidly evolving and has spawned many new approaches to health technology assessment.
Depending on the goals and preferences of a health system or payer, an HTA may be carried out as a stand-alone process or part of a larger price determination process. The latter usually entails negotiations between the manufacturer and health system or payer about prices for the technology. The negotiation process is usually based on an assessment of the price-effectiveness of the drug or technology and is often not completely transparent, as it requires that each party be willing to share relevant information about costs and savings.
Another approach to HTA is a “managed access” program. This is a recent development that allows manufacturers to obtain approval of a new technology based on less developed clinical trial results/data provided they collect more robust clinical data that will support its use in the real world. This is often called conditional approval and has the potential to accelerate the pace of a new technology’s access into a healthcare setting, while also potentially improving patient outcomes and decreasing treatment cost.
This type of process could be incorporated into the U.S. drug pricing landscape in the future, although it is likely that implementation will be complex. It will need to be adapted to the political environment and public distrust of government interference in healthcare. It will also need to incorporate a range of factors such as transparency, stakeholder engagement and the impact on access to the technology.
How is an HTA carried out?
Health technology assessment (HTA) is a process by which the properties of a health technology, including the medical, economic and social effects, are evaluated and compared to those of alternative alternatives. It is a systematic method that summarises the available information to help inform decision-making about new technologies in healthcare.
HTA is grounded in a variety of methods, ranging from policy analysis, evidence-based medicine and health economic evaluation to social science. It gives context-specific input to healthcare policies and decisions, which is important in ensuring that the right interventions are used at the right time.
In most cases, HTA is a two-part process. The first part, called assessment, involves systematic review and evaluation of scientific evidence about clinical outcomes and/or economic costs associated with a particular health intervention. This information is then used by the second part, called appraisal, to develop coverage recommendations.
Depending on the goals and preferences of the health system or payer, the HTA process can be implemented in different ways. For example, some countries choose to negotiate prices with drug companies. Others prefer to use risk-sharing schemes that allow companies to discount the list price of a drug in return for providing patients with better access to the medication.
The basic criteria that HTA bodies apply in their decision-making are the comparative clinical and cost-effectiveness of a new drug or technology to its existing standard of care. In addition to this, HTA bodies take into account the benefits that a technology or drug would bring to a health system and whether those benefits are worth the additional cost to the health system.
However, the complexities of implementing an HTA in the U.S., particularly when incorporating economic evidence, may make it difficult for HTA bodies to be influential in the coverage decisions of public and private payers. This is also true in Europe.
Hence, there is an urgent need to identify best practice for conducting HTAs across the European Union and its Member States. This will help to ensure that HTA is an effective and efficient tool for evaluating and informing the use of health technology and to contribute to a more sustainable and competitive healthcare system. The objective is to create a framework that is easy to apply and which allows HTA to become more transparent, consistent and effective.
What are the basic criteria that HTA bodies apply in their decision-making?
Health technology assessment (HTA) is a systematic process that helps governments and other decision-makers in health systems to assess the value of new medicines and technologies. This is a key part of policy-making in many countries. It is used to determine whether a medicine or technology should be made available and to generate guidance on how the new medicine or technology should be prescribed safely and effectively.
In HTA, the benefits of a drug or technology are compared with other treatments that have already been approved and are being used in the same patient populations in the health system under consideration. This comparative clinical and cost-effectiveness analysis is important because it helps the health system decide whether a new treatment offers genuine value to their health system at a price that they are willing to pay.
This is often done through a combination of different methods and approaches, depending on the type of HTA body that is carrying out the appraisal. Some are reliant on high-quality, rigorous studies while others rely more on qualitative research and a variety of other methods such as economic modelling and risk-sharing schemes.
One of the key criteria that are used by HTA bodies in their decision-making is to understand the impact that a new drug or technology will have on patients and their families. This can include what it means to their quality of life, their ability to function, and how their time spent with their family and carers is affected.
The patient and carer voice is often captured during the appraisal process through written requests for information or through participation in a face-to-face committee meeting. Some HTA bodies proactively contact patient and carer organisations to involve them in the appraisal process, and this can help shape the decision-making of the appraisal committees.
The HTA process is often very complex and a significant amount of work is required before any new medicine or technology can be made available. Therefore, it is important that patient and carer organisations have a strong understanding of the different steps of the process. This includes the development of submissions, the assessment process and the deliberations of the appraisal committees.
What is the impact of an HTA?
HTAs have become increasingly central to pricing and reimbursement decisions around the world, and there is growing interest in measuring the impact of these processes. However, there is limited evidence about the link between HTA and outcomes in terms of health improvements.
It is important that an HTA process produces results that are useful for policy makers and the public. These can include a better understanding of the costs and benefits of health technologies. They can also include evidence on how to best use these technologies for improving health.
There are several factors that influence the impact of an HTA, such as the nature of the decision made and the methods used to conduct it. It is also important to consider how the findings of an HTA are disseminated and what happens with them once they have been reported.
Ideally, a well-developed HTA process will have a positive impact on a range of stakeholders, such as the medical community, patients and industry. This is particularly true for medicines, where the process can help ensure that new medicines and technology are available in the health system at an early stage of their development.
In some countries, HTA bodies may also be involved in the development of regulatory pathways or other guidances for medicines and technologies. This can have a positive impact on the ability of health systems to make effective decisions about which technologies are likely to be of use.
Some countries are also working to promote “managed access” programmes for new drugs and technologies. These involve allowing a medicine to be approved on less robust clinical trial data, but with the condition that further research is conducted in order to demonstrate the effectiveness of the treatment. This is a valuable development for the future of the field of HTA, and can offer an earlier route to market.
A more recent development in the field of HTA has been to support the introduction of accelerated approval processes for new health technologies. These have been especially relevant during the pandemic, where regulators had to approve treatments for the flu in a much shorter time period than usual.