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HEALTHCARE REFORM

Lessons From The South

We need a serious conversation among experts over the right way to move foward on healthcare technology assessment.

PETER J. PITTS

The Burrill Report

“A good economic analysis is not a faultless crystal ball.”

Healthcare Technology Assessment is an innocuous sounding bit of bureaucratic-speak right down to its widely used acronym HTA. But it is not just a concept capturing the imagination of the penny-pinching set, which rightfully seeks to find means of measuring the cost, effectiveness and long-term impacts of specific technologies. Today, it’s a force readying to reshape healthcare not only in the United States, but across the globe.
Last week I participated in a two-day seminar held by the Consejo de Salubridad General of Mexico. The topic was “Pharmacoeconomics: a new age for decision making.” The seminar was designed to discuss Mexico’s new pharmaco-economic guidelines for their national formulary. And there was as much debate as discussion. The opening remarks by Stephano Bertozzi of the Instituto Nacional de Salud Publica set the tone for the event when he said, “We need to spend more and spend more wisely.”
Michael Drummond, professor of Health Economics at the University of York, delivered a primer on the various types of evidence used in HTA. Drummond’s take-away message was that decisions made via HTA are economic decisions—not necessarily medical ones. He also pointed out that using randomized control trails as the mainstay of comparative effectiveness measures was a flawed proposition and that other evidence—such as observational studies and real-time outcomes data needed to become part of the broader HTA equation.
I discussed how I believed that decisions should be made on patient-centric rather than cost-based platforms—and that reimbursement choices based on short-term budgetary considerations can be expensive for the government and dire for the patient. 

And then Jacques Lelorier, chief of the pharmaco-economics and pharmaco-epidemiology research unit at the University of Montreal, gave a provocative presentation on the gaming of the comparator issue in general and by Canadian authorities in particular—which does not tell the innovator company what comparator it has chosen and then, once a decision has been made, won’t share the data used in the process. He made the point (echoed by others during the course of the event) that when a particular HTA review finds a product to be outside of the selected cost-effectiveness parameters, “the answer is no,” but when the parameters fall within the selected criteria, “the answer is maybe.” 
During the second day of the seminar, several Mexican health officials and academics presented their views on pharmaco-economics and HTA. “Developing guidelines is one thing—making disastrous implementation mistakes is something else. We must have confidence in the people doing our HTA reviews and understand the relative strengths and weaknesses of the data,” said Atanacio Valencia of the Institudo Nacional de Salud Publica. “We must have clarity about appeal guidelines. A good economic analysis is not a faultless crystal ball. HTA has threats as well as opportunities.”
Being able to participate in the event and to see the Mexican public health community debate how to set up an HTA authority convinced me of five things:
1.      HTA can be a valuable tool when the right tools are used the right way;
 
2.      HTA must be a combined and collegial effort of government officials, trained academics, physicians and pharmaceutical companies;
 
3.      A variety of evidence must be considered—from randomized, controlled trials to observational studies to outcomes data;
 
4.      HTA must be as much a patient-centric proposition as a cost-effectiveness mechanism;
 
5.      All aspects of HTA—from the design to the decision to the appeals process—must be open and transparent
 
 
As we in the United States begin to think seriously about HTA, we absolutely must remember that it’s more than just “comparative effectiveness.” And a good way to start having a serious conversation about the issue would be to convene experts and discuss the right way to move forward.
I suggest that before legislators in the United States set up an American comparative effectiveness body within the Agency for Healthcare Research and Quality or anywhere else, they look at the process being used by our NAFTA neighbors to the South and carefully consider the warning of Professor Atanacio Valencia, who cautioned “Don’t make the remedy worse than the disease.”
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.


December 02, 2008
http://www.burrillreport.com/article-lessons_from_the_south.html

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