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Position Papers:
American College of Physicians*
Information on Cost-Effectiveness: An Essential Product of a National Comparative Effectiveness Program
Ann Intern Med 2008; 0: 0000605-200806170-00222-222 [Abstract] [Full text] [PDF]
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Electronic letters published:

[Read Rapid Response] Cost-effectiveness is very important in marginal benefit situations
Robert A. Murden, Eric E. SeiberCost-effectiveness   (15 July 2008)
[Read Rapid Response] Response to Editorials on "Information on Cost Effectiveness" Position Paper
Neil M Kirschner, Stephen G. Pauker, Joseph W. Stubbs   (19 June 2008)
[Read Rapid Response] National Comparative Effectiveness Program-Issues for Clinical Practice
Arvind R Cavale   (20 May 2008)

Cost-effectiveness is very important in marginal benefit situations 15 July 2008
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Robert A. Murden,
MD
The Ohio State University,
Eric E. SeiberCost-effectiveness

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Re: Cost-effectiveness is very important in marginal benefit situations

robert.murden{at}osumc.edu Robert A. Murden, et al.

To the Editor,

We read with interest the position paper on a National Comparative Effectiveness Program(1) and the related editorials. This is very timely as there is general agreement that the growth in health care spending in the US is unsustainable. We contend that one of the most increasingly important contributors to rising costs is innovations with marginal benefits, and the only way to assess the benefit/financial risk ratio of these marginal benefits is precisely to tie cost-effectiveness with clinical effectiveness. This is best demonstrated with an example.

In 1996 the CAPRIE(2) study showed the clinical effectiveness of clopidogrel over aspirin, demonstrating an 8.7% relative reduction in recurrent stroke, peripheral vascular disease, and myocardial infarction. If clinical effectiveness and cost-effectiveness considerations were divorced from each other, as suggested by Dr. Wilensky(3), there would be no further discussion. However, the reported recurrent event reduction, from 5.8 to 5.3% per year, is more importantly an improvement in prevention success rate from 94.2% per year with aspirin to 94.7% with clopidogrel, a marginal improvement amount that will likely be quite common with future innovations since our healthcare system has achieved great baseline success in many areas.

Furthermore, a cost-effectiveness measure is essential in this example, both individually and collectively, since clopidogrel costs about $1560 per year, versus $15 for aspirin. Individually, the proposed incremental cost-effectiveness ratio would be $309,000 per event prevented. Collectively, the annual prevalence of the three target diseases in 2001, shortly after CAPRIE was published, was 25.8 million people(4), and assuming about 15% of them have a dual diagnosis, that leaves 22 million different individuals. Treating all of them with clopidogrel would have cost 34 billion dollars a year more than treatment with aspirin alone, which would have accounted for 28% of all US pharmaceutical costs, and 2.5% of all US health care costs(5) at that time, for that one innovation to improve success from 94.2 to 94.7%.

This kind of information is critical if physicians, patients, payers, and/or policy makers are to make rational decisions to stem the out of control health care expenditures that threaten our health and our economy. In this era of numerous marginally beneficial innovations with variable cost increments, the entity proposed by the American College of Physicians is crucial to provide information we all need.

Robert A. Murden, MD Professor of Clinical Medicine Department of Internal Medicine The Ohio State University

Eric E. Seiber, PhD College of Public Health The Ohio State University

References:

1. Information on cost-effectiveness: an essential product of a national comparative effectiveness program. American College of Physicians. Ann Intern Med. 2008;148:956-61. 2. CAPRIE Steering Committee. A randomized, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996;348:1329-39. 3. Wilensky, G. Cost-effectiveness information: yes, it’s important, but keep it separate, pease. Ann Intern Med. 2008;148:967-68. 4. Heart disease and stroke statistics. American Heart Association, 2004. http://www.americanheart.org 5. Davis K, Schoen C, Guterman S, Shih T, Schoenbaum S, Weinbaum I. The Commonwealth Fund. Slowing the growth of U.S. health care expenditures: what are the options? January 2007, Commonwealth publication #989. www.cmwf.org

Conflict of Interest:

None declared

Response to Editorials on "Information on Cost Effectiveness" Position Paper 19 June 2008
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Neil M Kirschner,
Ph.D
American College of Physicians,
Stephen G. Pauker, Joseph W. Stubbs

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Re: Response to Editorials on "Information on Cost Effectiveness" Position Paper

nkirschner{at}acponline.org Neil M Kirschner, et al.

To the Editor:

Drs. Garber (1) and Wilensky (2) both recognize the importance of information about comparative effectiveness and cost in making rational choices among alternative therapies. Extending Garber’s analogy, without information about comparative effectiveness and cost-effectiveness not only are we ordering from a menu without prices but, for many, from a menu written in a foreign language. Both components from a trusted source are needed to make rational, effective healthcare decisions.

While recognizing Wilensky’s superb knowledge of political realities, we disagree strongly with her call for a separate entity (i.e. the payers) to develop unbiased data on cost-effectiveness. Studies of comparative effectiveness and cost-effectiveness are commonly done together (as in the United Kingdom’s National Institute for Health and Clinical Excellence program), whether within a clinical trial or in analyses of data from combinations of trials. Requiring investigators to seek funding from two different entities would impede progress. Furthermore, leaving cost- effectiveness analyses to the payers, as Wilensky suggests, also would bring into the question the trustworthiness of the results. Payers have their own interests and perspectives and do not always provide unbiased, transparent analyses.

While there is clearly a difference of opinion on whether the production of comparative effectiveness and cost-effectiveness information should lie within the scope of a single entity or more than one, this disagreement should in no way weaken the College’s position that cost is important, that its use must be transparent, and that cost should never be compared without simultaneously considering comparative clinical effectiveness.

1. Garber AM. A menu without prices. Ann Intern Med. 2008;148:964-966

2. Wilensky GR. Cost-effectiveness information: yes, it's important, but keep it separate, please! Ann Intern Med. 2008;148:967-968

Conflict of Interest:

None declared

National Comparative Effectiveness Program-Issues for Clinical Practice 20 May 2008
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Arvind R Cavale,
MD, FACE, FACP

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Re: National Comparative Effectiveness Program-Issues for Clinical Practice

mdllcoffice{at}gmail.com Arvind R Cavale

It is admittedly time for the nation to openly discuss cost- effectiveness in health care; therefore this proposal from the ACP is timely. Being a solo practitioner, I view this type of "top-down" policy as similar to some of the previous mandates that may have actually lead us to this situation.

While agreeing with most of the principles in theory, I have reservations about how these might affect community-based clinical practice. First, if such a program is ever implemented, every practice will have to rework every insurance contract that each physician currently has, leading to significant (unfunded) expenses, which hurts small practices the most. Physicians may just opt out of participating in insurance plans/Medicare if they are mandated to do so.

Second, if such a cost-effectiveness policy has to be implemented in clinical practice, the current practice of prior- authorisations/preapprovals has to be eliminated. The basic premise that a non-clinician in an insurance company/Medicare/Medicaid can override a clinical decision made by a physician after a thoughtful clinical evaluation, must be eliminated.

Third, while a federal agency is fine to initiate the process, state- based subsidiaries must be created to set cost-effectiveness standards based on local issues - such as population characteristics, average education level and types of employment and even local weather patterns. For example, reimbursement for language translators may be highly cost- effective in certain neighborhoods, whereas provision of transporation may be cost-effetive in others. Only people with knowledge of local conditions will be able to figure these things - national agencies will not.

Fourth, prior to such a program being implemented, physicians have to be provided with legal immunity against litigation, in case of less-than- favorable outcome related to use of a particular cost-effectiveness program. Without such protection, physicians are highly unlikely to discuss cost-effectiveness issues with a patient. It is vitally important for the authors to remember that the primary intent of a clinical decision is almost always the benefit to a patient. The general public also expects no less from their physicians. Adding a cost variable to this equation will most likely erode the strenght in the physician-patient relationship, which has already reached a low point, in my observation. Therefore, this effort has a better chance of success if it starts at the community level and works towards the provider level.

Fifth, with respect to technical details about "cost" and "effectiveness", it has to be clearly stated that "cost" is "allowable cost" and not "billed cost". And similarly, effectiveness must be disease- specific not episode-related. For example, it may cost more upfront to use a newer medication, but over time it may save in terms of avoiding all the adverse effects attributable to a comparable older agent. Similarly, it may be expensive to reimburse for disease-specific patient coaching, but it may prove cost-effective in the long term if this prevents recurrent hospital visits. So, the devil is in the details.

And finally, one would expect that an organisation (ACP) representing physicians, would make a clear distinction between "explosion of health care costs" and health insurance costs. As a practicing physician who has seen incomes stagnant over the past ten years despite marked increase in workload, I refuse to accept the statement that "explosion of health care costs" justifies the use of cost-effectiveness measures, because it legitimizes the notion that cost increases are a direct direct result of over-utilisation of ineffective care. In my opinion, the College would serve a greater purpose if researchers could analyze what percentage of increases in insurance premiums has actually translated into increased payments for health care and what percentage has percolated into the coffers of insurance companies.

I applaud this effort from the ACP, but would like specifics to be added in the future.

Conflict of Interest:

None declared


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