Our goal in formulating the proposed principles was to stimulate discussion of HTA program goals and procedures to enhance the rigor, validity, and usefulness of HTA. The thoughtful and constructive comments by David Banta, David Hailey, and Duncan Neuhauser are an excellent beginning to what we hope will be an extended and interactive process. We appreciate the opportunity to respond to some of their comments, suggestions, and critiques.

As noted in the title, the focus of our study was on HTAs for resource allocation decisions. Neuhauser sees this as a strength, but Banta questions this narrow focus. There were three reasons for this strategy. First, as Banta himself points out, activities labeled as HTAs comprise a very diverse set, some of which have nothing to do with cost-effectiveness or resource allocation.

Second, one of the main developments in recent years is that, in several jurisdictions, HTA has changed from being an activity where HTA entities mainly issue reports, to one where HTAs are hard-wired into decisions about coverage or access to therapies. Because these decisions clearly impact on resource allocation, it is important that the associated HTAs embody most of the principles we outline.

Indeed, Banta states our central point well. “Implicitly, by definition, the group seems to consider that all resource allocations require economic analysis, or conversely, that HTA decisions that do not include economic analysis do not deal with resource allocations.” To the extent that some HTAs do not consider costs, yet concern decisions that affect the use of healthcare resources, they provide insufficient data for making the decision.

Third, the focus on resource allocation reflects the area on primary expertise, experience, and academic strength of the group; economic evaluation of healthcare interventions. Of course, HTA is a multidisciplinary activity. Indeed our group includes individuals with backgrounds in clinical medicine, pharmacy, epidemiology, economics, management, and engineering. In addition, several of us are producers and consumers of HTA, in our role as decision makers on public bodies like NICE in the United Kingdom, or as members of public and private sector national guideline and advisory committees, and formulary committees for hospitals or health plans in the USA.

Both Banta and Hailey point out that several of the principles are rather idealistic, or unachievable, and that there are conflicts between, on the one hand, being timely and, on the other, being rigorous. However, these principles are also forward looking; they were developed to guide the future conduct and evolution of HTA to inform healthcare resource allocation decisions. While we recognize the need for flexibility, we firmly believe that statements of good practice are essential. We have not heard anyone argue that good quality clinical care should not be defined because it is difficult to achieve in many circumstances. As Neuhauser notes, “Governments and insurers must decide what care and treatments to pay for. HTA undertakes to answer this perennial question in a reasoned way. . .HTA answers must be [both] rapid and accurate enough to stand up to challenge.”

The trade-off between quick and timely answers and more detailed analyses is both extremely important and challenging. A natural experiment is currently under-way in the UK, where NICE is being requested to do more, but less detailed, assessments of new technologies. In the United States, some private and public sector groups are also experimenting with HTAs of varying depth, breadth, and rigor. The outcomes of these developments should be monitored. It is possible that some compromises in methods or processes are unwise and that HTA agencies should be wary of this when negotiating their remit with their governments, or parent organizations.

Hailey observes that many of the points we make are best aimed at decision-makers, rather than individuals working within HTA programs. We consider both groups to be audiences for the paper. In particular, we believe that the proposed principles should be considered by public and private organizations seeking to establish or strengthen HTA programs, as well as HTA programs themselves, as they continue to evaluate and evolve their procedures and methodologies.

Both Banta and Hailey comment on the issue of setting priorities for HTA. Hailey makes the excellent point that some technologies that are relatively underassessed (e.g. rehabilitation programs) have not necessarily been overused. We agree. Perhaps the role of HTA in such cases would be to establish value for money, so that more use could be encouraged. However, there are many more examples of rapid proliferation of technologies (e.g., imaging and physician procedures) that have been subjected to only limited assessment. Banta points out that there is industry funding for some technology assessments but not others. Again we agree, but this underscores that HTA is a public good for which greater public funding and support is required.

Finally, Neuhauser points to new developments in the field, such as “prognostic markets,” or “personalized medicine.” These will add both to the challenges and opportunities for HTA.

It is not for us to say whether our principles are helpful, or better or worse than previously proposed principles and guidelines, many of which informed our work. However, as our examples demonstrate, there is considerable variation among HTA programs worldwide, and many situations where practice falls short of the ideal. This suggests to us that continual re-statement of key principles will do more good than harm.

The demand for rigorous, valid, and timely HTA for resource allocation decisions is growing rapidly. The proposed principles represent our attempt to identify the key issues, areas in need of improvement and methods to enhance HTA activities and programs. We look forward to engaging in thoughtful and constructive debate with colleagues from a wide range of disciplines and a broad spectrum of experiences.