Every day new medical technologies are launched with the potential to improve patient outcomes and refine health system efficiency. Health Technology Assessment (HTA) was created as a tool to review these technologies and provide evidence of their value for healthcare systems and patients.
As defined by the International Network of Agencies for Health Technology Assessment (INAHTA), HTA is the “systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies”
The role of HTA has been described as a bridge between research and decision-making. However, the true value of HTA in a health system depends on its impact on healthcare quality rather than on increased knowledge.
What is the implication of HTA reports for medical companies? When and how should the information be considered for commercial and market access strategies?
Lack of purpose?
With an internet connection, it is relatively simple to find any HTA publication nowadays (even though there are paid services for it). The significant wealth of knowledge usually adds to the confusion, as different HTA agencies have different opinions about the same technology or intervention.
Taking one step back, what would be the expected impact of an HTA report? Surprisingly, HTA reports usually do not clarify the outcomes they would like to achieve, such as influence over coverage decisions, support guideline formulation or change routine practice. Although most HTA reports have defined objectives, they usually do not link them with real practice, and it is up to physicians and providers to determine the best course of action. Typically, this means ignoring HTA reports all together.
HTA reports have a higher likelihood of being implemented when they are bound to a healthcare policy process or funding decision. For example, the National Institute for Health and Care Excellence (NICE)issues technology appraisals guidance that require clinical commissioning groups, NHS England and local authorities to comply with them within 3 months of its date of publication.
Duplication of work
One of the main challenges for companies is to decide where to apply for an HTA assessment, since there is no single methodology that is accepted by all international agencies.
Image credit: Open Access BPO
The European Network for Health Technology Assessment (EUnetHTA) addresses this issue with joint assessments that bring together 2 or more countries, or HTA agencies, to prepare shared assessments or agreed outcomes. The EUnetHTA also maintains a list of national uptakes, describing situations when their reports were influenced or were used as basis for local reports. For example, the Spanish HTA Network developed the adapted national guidelines for Relative Effectiveness Assessment (REA) reports (“Guía para la elaboración de informes rápidos de evaluación de tecnologías sanitarias”), based on the EUnetHTA guidelines for REA. Such initiatives help reduce duplicated efforts and create conditions for a more effective use of time and financial resources of evaluators, companies and others.
Fact is, HTA reports address local needs and questions from policy makers in the regions where they are carried out. Thus, the creation of a so-called “European HTA framework” would require the coordination of international clinical policy-making, which, realistically, is unlikely to occur.
Instead, harmonization efforts, such as those provided by the EUnetHTA, offer transparent and transferable information with the aim to contribute to HTAs in European countries, with the added benefit of understanding local reports will always be necessary.
New versus established products
In general, the contribution of HTA reports is stronger for new technologies versus those already established. This is because HTAs are not developed to change how clinicians and other professionals deliver care.
HTA reports are mainly performed to evaluate technologies or interventions towards clinical policies. Their format and structure are not suitable to the needs of physicians, who must apply Evidence-Based Medicine and medical knowledge to treat patients. Instead, HTAs consider the perspective of a system and the potential impact of incorporating or not incorporating certain technologies.
In that sense, technologies already adapted or present in a certain market will hardly be influenced by new HTA reports. However, exactly the opposite is true for new technologies. Their usage and adoption, on the other hand, are heavily influenced by HTA reports, especially when they represent a high level of budget impact.
Implications to business strategy
Local market decisions, such as reimbursement and adoption, are usually not influenced by international HTA reports, and when they are, there is always the need to evaluate the technology or intervention under the local perspective.
In fact, HTA conclusions provide little value for companies in terms of their commercial or market access strategies. It is certainly important to monitor the conclusions from different agencies around a certain medical product, however, local adoption is much more dependent on aspects like value demonstration, training, professional education and service delivery.
In addition, positive HTA appraisals do not significantly influence decision-makers, who typically prefer to ignore the reports. By contrast, negative HTA appraisals are quickly used as part of the rationale to decline reimbursement or purchasing.
From that perspective, most HTA evaluations bring significant risk with limited level of benefits for medical companies.
When is an HTA worthwhile then?
New and high-cost technologies are better suited for an HTA assessment. However, companies must be confident about the level of evidence and clinical outcomes of their products, since a negative HTA report can create significant impact to business.
In contract, companies should plan on how to leverage the use of positive HTA reports. If they leave it to the markets, such positive appraisals will remain on the shelves of digital databases. The question is: “how can we accelerate the adoption of our technology in case we obtain a favorable HTA result”?
An even better question would be “do we really need an HTA to promote the value of our technology”?
We do not intend to criticize HTA reports or methodologies. On the contrary, our intention is to demonstrate they are part of a complex healthcare system that must consider different stakeholders’ needs and opinions when making a decision.
In that sense, HTA is not the complete answer, rather only a part of it.
Are you assessing whether or not to submit your technology for an HTA evaluation? Are you confused about which countries/agencies to prioritize? Send us your questions at [email protected], and our team will be happy to discuss your options under a pragmatic approach.