Evaluating high-cost technologies – no need to throw the baby out with the bathwater

ABSTRACT

Introduction

Evidence generation for the health technology assessment (HTA) of a new technology is a long and expensive process with no guarantees that the health technology will be adopted and implemented into a health-care system. This would suggest that there is a greater risk of failure for a company developing a high-cost technology and therefore incentives (such as increasing the funding available for research or additional market exclusivity) may be needed to encourage development of such technologies as has been seen with many high-cost orphan drugs.

Areas covered

This paper discusses some of the key issues relating to the evaluation of high-cost technologies through the use of existing HTA processes and what the challenges will be going forward.

Expert opinion

We propose that while the current HTA process is robust, its evolution into accommodating the incorporation of real-world data and evidence alongside a life-cycle HTA approach should better enable developers to produce the evidence required on effectiveness and cost-effectiveness. This should lead to reduced decision uncertainty for HTA agencies to make adoption decisions in a more timely and efficient manner. Furthermore, budget impact analysis remains important in understanding the actual financial impact on health-care systems and budgets outside of the cost-effectiveness framework used to aid decision-making.

KEYWORDS:

• High-cost technologies
• health technology assessment
• evidence generation
• real-world data
• life-cycle health technology assessment

Article highlights

• Reimbursement of high-cost technologies can differ between countries for many reasons as can the involvement of managed access routes to allow quicker decision-making.

• Health technology assessments are rigorous and evidence-based process but are often used late in the product development cycle. However, recent years have seen a push from both the public and private sector toward using real-world evidence to speed up adoption decisions allowing patients faster access to technologies.

• The earlier use of real-world evidence needs a greater understanding on the impact it could have on the generation of evidence required for robust and rigorous decision-making and where the risk and cost of development falls.

• Life-cycle health technology assessment should be routinely used for all technologies, include reevaluation and not just focus on the evaluation of new high-cost technologies.

Declarations of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.