NEW YORK (360Dx) – AdvaMed, the advanced medical technology association, and its AdvaMedDx division, which represents manufacturers of diagnostic tests, has teamed with industry stakeholders to develop a framework for the "comprehensive assessment" of the value of diagnostic tests.
Last week, as part of a drive to make people more aware of the framework, AdvaMed's Vice President of Payment and Healthcare Delivery Policy Chandra Branham presented some of the fine points of the work at the 11th Semi-Annual Diagnostic Coverage & Reimbursement Conference in Boston.
Branham this week also spoke with 360Dx about vital components of the framework and how diagnostics organizations could apply it.
Below is an edited version of the interview.
What inspired the development of the framework and what is its main objective?
We've been talking about the value of diagnostics for several years within the various workgroups that we run with our member companies, which are diagnostic test manufacturers. And we've been thinking through the best ways to demonstrate the value of diagnostics to stakeholders. The idea for a formal value framework grew from these conversations. A few years ago, we saw other frameworks starting to emerge, such as the ICER Value Assessment Framework [developed by the Institute for Clinical and Economic Review, which assesses the clinical effectiveness and value of drugs] and others. A lot of the frameworks that we saw emerging focused on pharmaceuticals, but not so much on diagnostics or medical technologies.
AdvaMed decided that it needed to develop something that specifically looked at diagnostic tests.
With whom did you engage in developing the framework?
First, our member companies, manufacturers of diagnostic tests, were interested in working with us. But we also reached out to the American Clinical Laboratory Association, the National Independent Laboratory Association, the Association for Molecular Pathology, and other associations. We reached out to some large payors, including UnitedHealth Group, Blue Cross Blue Shield, Aetna, and Kaiser Permanente, as well as to Mayo Medical Laboratories, which is a payor and provider. The stakeholders included test providers, payors, clinical laboratories, patient advocates, and professional medical associations, among others.
What was the main reason for including a broad range of entities, including payors? Were you ensuring that you would create a robust framework, or was it part of a strategy to help drive adoption when the framework was eventually developed?
We wanted to develop a framework that expanded the concept of a value framework beyond clinical utility. In part, we wanted to see whether other stakeholders also saw things along those lines. We weren't sure if payors were considering a broader definition of value, and including some non-clinical patient impacts, such as whether a [new] test is more convenient to use than an [older] existing test, an area related to patient satisfaction. Part of including a breadth of entities had to do with finding out if we were moving in the right direction ourselves. But part of it also had to do with finding out if there would be buy-in from entities such as the payors, and whether they would they be interested in adopting an approach such as the one we were developing.
What are some of the most important value principles that are part of the framework, and how important are they to the overall initiative?
Our first step was to try to coalesce around a set of high-level principles that should be part of a framework. For instance, one of the important properties of a framework is that it must be flexible. One diagnostic test's characteristics may look different from the characteristics of another test, so all factors don't weigh equally in every case. The principles we identified relate to comprehensiveness, evidence, cost, specificity, flexibility, engagement, transparency, and relevancy. As an example, the specificity principle states that value assessments should account for representative patient populations and applicable timeframes for patient impact. The engagement principle states that a value assessment process should involve the perspectives of multiple stakeholders and provide sufficient opportunities and time for all to engage in the process.
As a result of identifying these principles, you created a comprehensive approach to value. What are some of the main elements of that approach?
The comprehensive approach that AdvaMed developed focused on four value drivers, or components of value — the clinical impact of the test; the non-clinical patient impact; care delivery revenue and cost impacts; and population health impact. An example of tests that have a population health impact are the Zika tests that were developed very quickly after that outbreak. Of course, every test doesn't have to demonstrate a broad population impact, and that's why the framework is inherently flexible.
Not all the value drivers and their subcomponents have to apply to every test, but you do weigh the value of each relevant criterion against each test?
That's why the framework must be flexible. The test might not have a broad population health impact, for instance, but may demonstrate value in other ways. For example, a patient may be able to perform the test at home rather than having to go to a clinic or other setting, which could drive value by being easier to administer or reducing the amount of time that the patient must take off from work.
Are there other factors affecting the analysis of a diagnostic test?
Yes. These might include the test's relevance to certain patient populations: the type of test, for example, whether it is a screening, diagnostic, or prognostic test; and the timeframe factors that impact value. The time to get to a result in certain applications could impact value for some tests, for instance, or a test that you can take once and don't have to take again for a few years might add value in a different way. Again, this is not a criterion that has to apply to every test, but there could be something interesting about a timeframe with respect to a test that gives it some added value.
By incorporating all these value drivers and other factors, you created the comprehensive approach for assessing a diagnostic test's value. What are some of the benefits a stakeholder gets from the framework?
The framework takes you through a systematic process of looking for value. You can summarize what you find in a succinct and orderly way, and know that you haven't left anything out. You might want to select relevant parts of the framework so that you can tailor your description of a value proposition toward a specific type of stakeholder. If you are presenting your value case to a physician specialty society, for instance, you might tailor the value proposition to point to the value drivers most relevant to obtaining buy-in from the physicians that might use the test. The physician group could, for instance, be interested in test features such as ease of use; an improved result; and a faster time to diagnosis, so that you could treat a patient immediately in the office instead of relying on them to come back later for treatment. That, in turn, could improve compliance and health outcomes. However, you might have a different value proposition if you are targeting the test to a hospital system where they are looking at whether your test can offset costs in another way, such as reducing the number of hospital visits.
Within the framework, how important is evidence support?
One of the principles is that any framework should rely on appropriate evidence to support value claims. We created a separate report regarding the value of evidence to support the value of medical technologies and diagnostic tests. It's an assessment of the various types of evidence that can be developed. We suggest that everything doesn't have to undergo a randomized controlled trial to demonstrate value. Some payors feel strongly that randomized controlled trials are the gold standard. We respect that there is a hierarchy of evidence required to prove the value of a test, but we also think that there is value to be obtained from considering a broader range of evidence.
What are some examples of use cases for the framework?
To demonstrate its use, some of our members agreed to take their own product through the framework and create a report. We wrote a report along with the manufacturers for each of three diagnostic tests. One, the Abbott Architect antibody-antigen HIV assay, was a rapid test. We walked the product through the framework and analyzed multiple criteria. For example, with respect to patient need, Abbott identified the number of patients living with HIV in the US and identified those patients as the relevant population. There were a couple of different ways to look at timeframes with respect to the test. It provided a fast result, in less than 30 minutes, and that fed into patient compliance. Overall, because of the test, there were fewer instances of patients leaving and not coming back to the clinic.
The other two tests were Exact Sciences' Cologuard, which we selected because as a screening test, it was different from the rapid test, and an Abbott Vysis ALK Break Apart FISH Probe Kit, which was different again, because it is a companion diagnostic test to determine if patients would respond to a specific therapy for non-small cell lung cancer.
Do you have examples of diagnostic industry stakeholders applying the test, and what are your next steps?
As far as next steps, we continue to roll this out and talk about it in forums like the conference in Boston. There's been significant interest in applying the concept because it is focused more on technology than pharmaceuticals, and because it is focused on providing a broad approach to analysis — which offers more to stakeholders than boiling the test's value down to a number.
Some of our members are not only interested in the concept, but they have also used the framework to help them guide a discussion with a payor.
We believe that there are many ways organizations can use the framework. Just as you can tailor it to present a value proposition to different stakeholders outside your company, you could use it to gain a common-page understanding of the value story among stakeholders within the company. This could be accomplished at the beginning when the company is starting to develop the test or later when they are looking to have the test more broadly adopted.