Thursday, September 15, 2016

How To Think About Health Technology Assessment: A Response To Goldman And Coauthors

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From 3,000 miles away—on the other side of the Atlantic and more precisely from England—it is hard not to sense a note of frustration in the Health Affairs Blog post by Dana Goldman, Sam Nussbaum, and Mark Linthicum: “We need health technology assessment. Only we can’t have it. Because we are us. But we need it. But we can’t have it. So what do we do?”

It is also hard not to offer sympathy, not least because every country that has what the three authors dub “full” health technology assessment (also referred to here as “HTA”) finds it endlessly controversial. But at least some of the dilemma that they seek to address arises from constructing straw men, not least their distinctions between “European-style” HTA, “full” HTA, and the United States.

Is There Such A Thing As ‘European-style’ HTA?

Let’s start with “European-style” HTA. Health technology assessment is indeed used in much of Europe, but also, as Goldman and coauthors partially acknowledge, in many other countries: not just Japan, Australia, and Canada, but also New Zealand and, on a small but growing scale, a number of African and Asian nations.

Quite how HTA is used differs within Europe let alone elsewhere. And the context in which it operates varies widely, from single-payer systems of the type seen in the United Kingdon and parts of Scandinavia, to multi-payer systems as in the Netherlands. The way HTA operates in Australia is different from the way it operates in the UK. So, other than at a highly conceptual level, there really isn’t such a thing as “European-style” HTA with which to contrast the US.

Undertaking HTA Is One Thing. Applying It Is Another.

Goldman, Nussbaum, and Linthicum then draw a distinction, not an entirely clear one, between undertaking health technology assessment and doing what they dub “full” HTA. Lots of countries and many more institutions undertake health technology assessment. As the authors note regretfully, the US was indeed one of the pioneers when it set up the Office of Technology Assessment in the 1970s; the OTA produced, as they put it, “well received” reports until it was abolished in 1995 due to a “political backlash.”

Undertaking HTA as a form of academic exercise, however, is one thing. Getting the results applied is quite another. That is what it seems Goldman and his colleagues mean when they contrast HTA with “full” HTA — in other words, getting to a position where if something is demonstrably not cost-effective, then funders will not fund it.

Now it is obviously true that this is much easier to do in a single-payer system such as the UK’s four different versions of a National Health Service. But to varying degrees the findings from health technology assessment are used to make funding decisions in countries that do not have single payers: in France, Germany, and the Netherlands, for example.

Even in the United States, there are some “single payers”—Medicare and the Veterans Administration, for example—while large health insurers such as Humana, United, and Kaiser also use HTA to inform at least some coverage decisions.

So the contrast between “European-style HTA” and the US is something of a false one. The real contrast Goldman and coauthors seem to be making is less whether health technology assessment exists, but whether there is a national body with at least some direct influence or indeed decision-making power over what is and is not funded.

Clearly, in the United States, there is no such body, and no immediate prospect of creating one. The politics don’t work. The US reliance on competitive employer-based health insurance, set alongside the segmentation of publicly funded coverage into Medicare (the older population), Medicaid (the poorer population), and the Veterans Administration (vets) militates against that. So do some of the values that Goldman, Nussbaum, and Linthicum highlight, including an apparently greater willingness than in some other countries to accept inequality in health outcomes based on an individual patient’s ability to afford care.

Having Health Technology Assessment Does Not Create An Ice Age

The authors also paint “European-style HTA” as a static process against some US ideal of a dynamic one. There is a grain of truth in that, but the picture is not as black and white as it is painted. In the UK, for example, the National Institute for Health and Care Excellence’s (NICE) recommendations are revisited as and when new evidence emerges. That does, of course, produce a time lag between the evidence emerging and a different decision being made.

But it is not the case that there is no price negotiation, or indeed price change, for particular pharmaceuticals and technologies — it is just done in a peculiarly British way. If a treatment is too costly to come in under NICE’s threshold for cost-effectiveness, companies can negotiate a “patient access scheme” with the health department. These operate in a number of ways, but in practice they provide an—undisclosed—price discount to the National Health Service, so that the treatment is in fact available at a price below the headline one. There are currently more than 80 such schemes in operation.

The UK’s recent experience with cancer drugs also illustrates that the approach is not static. Back in 2010, the government created a separate fund, the “Cancer Drugs Fund,” to pay for cancer treatments that were too costly to fit NICE’s criteria. That turned the NHS into a price-taker for these costly treatments and the fund repeatedly busted its budget. More recently, assessment of the cost-effectiveness of these treatments has been returned to NICE and the result has been significant price cuts on a number of these products.

The Case For HTA Is ‘Unassailable’

As the authors state, the case for health technology assessment “to better distribute limited health care resources to maximize health,” is “unassailable.” Even in a country as rich as the United States, there will always be some limit on the amount spent on health care, and spending on the ineffective will crowd out spending on the effective (as well as, more than likely, doing harm).

The question is how to do it, and the answer to that is likely to vary country by country. The reason for that, of course, is that HTA involves a series of judgments: judgments over what weight to put on the scientific evidence, and how to evaluate this evidence; judgments about where the threshold or thresholds for cost-effectiveness should lie. And then there’s a whole set of social value judgments—for example, should the threshold for what is funded be higher or lower for “end-of-life” treatments, or for children, or for patients with rare diseases where the cost of treatment is likely to be high because there will only ever be a small market for the product? And so on. Those questions are unlikely to be answered in the same way everywhere.

The Challenge Is The Same Everywhere

The challenge the authors set out in their closing paragraph—how to design a system that measures value appropriately, links reimbursement to that value, and does so in a way that stimulates innovation—is one that everyone involved in HTA would recognize. These are issues that countries that already have well established approaches to HTA live with continuously. Moreover, how HTA is applied will inevitably evolve as science and medicine evolve, and as health budgets expand or contract, throwing up new challenges over how cost-effectiveness should be judged.

But in thinking how HTA can be better used in the US, it is not clear that seeking to contrast the United States with a “European-style” approach is particularly helpful.



from Health Affairs BlogHealth Affairs Blog http://ift.tt/2caLrDZ

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