WASHINGTON _ In the cacophony of the health care reformdebate, even would-be drug price controllers and devout free-marketers seemed agree on one thing _ the inevitability anddesirability of cost-effectiveness studies for new medicaltechnologies.
Cost effectiveness analysis (CEA) was hailed as a potential panaceafor the spiraling cost of health care in the U.S. and the overuse orunderuse of drugs and procedures.
Despite all the positive press, CEA may not have real cost-savingpotential and it remains an unproven and fledgling art, according to agovernment report quietly released last October. The Office ofTechnology Assessment (OTA) prepared its study of CEA, entitled"Identifying health technologies that work: searching for evidence,"in response to a request from the Senate Committee on Labor andHuman Resources.
Health care reform aficionados may recall that the former chair ofthat committee, Sen. Edward Kennedy (D-Mass.), was also a keyarchitect of a proposal to replace the breakthrough drug committeewith a government-led study of the cost effectiveness of new andexisting drugs and technologies. In Kennedy's plan, the Agency forHealth Care Policy and Research (AHCPR) would conduct thestudies. The AHCPR proposal died last year along with countlessother schemes to reform health care.
The OTA report concluded that although the federal government hasboosted its efforts to identify which current health technologies andpractices work better than others, research findings have providedfew definitive answers.
"The hopes for `effectiveness research' are not entirely misplaced,but they have been overly optimistic and often misdirected," wrotethe report's authors. "Implementing the findings of valideffectiveness research will probably improve the quality of healthcare, but will not necessarily reduce health care costs significantly."
Congress established AHCPR in 1989 to weed inappropriate andineffective care out of current clinical practice, wherever possible.But according to the OTA, the agency has completed few studies thatactually identify the most effective medical technologies andpractices. Indeed, the OTA found that currently AHCPR has neitherthe mandate, the commitment nor "the leverage" to "successfullycoordinate the effectiveness research" efforts of the federalgovernment.
The rising health care costs that spurred attempts to overhaul theU.S. system will likely remain a serious problem. The OTA reportadvocates that the federal government _ as one of the nation'slargest single purchasers of health care (through Medicare andMedicaid) _ should thus increase its commitment to andengagement in cost effectiveness research.
But government-led efforts to refine and standardize CEA may onlybe playing catch-up to the private sector. "Cost-conscious managedcare administrators and other prudent health care purchasers" havegot private sector providers scrambling to prove that their productsare effective and economical.
"As the use of CEA increases, attention to the validity andcomparability of analyses becomes crucial. Inconsistencies amonganalyses in the approaches and assumptions they use will confusepolicy-makers and hinder the practical use of CEA," stated the OTAreport.
"To the extent that the results of these analyses are used in marketingclaims, both purchasers (e.g., government and private insuranceprograms) and regulators (i.e., the FDA) will need to becomeincreasingly sophisticated at evaluating the claims. Given thegrowing level of interest among private and public policy-makersalike in CEA, the federal government's level of activity in this area issurprisingly weak," the report concluded.
Federal efforts to evaluate health care technologies are hampered bythe fact that the justification for most medical practices used in theU.S. today rests on the experience and expertise of clinicians andpatients rather than on "objective evidence" that these practicesimprove people's health, according to OTA. However, it's well-known that many technologies, such as routine chest X-rays, can beineffective. Likewise, many surgical procedures remain unprovenand are likely unnecessary.
During the health care reform debate, some pharmaceutical andbiotechnology industry executives raised the possibility that drugscould pass cost-effectiveness exams with flying colors. In manyinstances, drugs are considerably cheaper than surgery orhospitalization.
However, without the impetus of comprehensive health care reform,it's unclear how many drug companies would welcome increasedfederal efforts to evaluate the cost-effectiveness of their products.The OTA report offered a range of policy options that lawmakerscould pursue in boosting the government's role in CEA methodologyand practice. Suggestions for "filling the gaps" in cost-effectivenessresearch include:
* Improve the efficient production of meta-analyses and othersystematic reviews of existing studies, to make best use of pastefforts at clinical evaluation.
* Conduct more, and more efficient, clinical trials that yield validcomparative information on health technologies already in use, toproduce results directly useful to patient and physicians decision-making; and make valid, well-designed comparative studies anintrinsic part of ordinary practice in every setting.
* Encourage greater comparative evaluation of newly introducedtechnologies (this could include offering incentives to manufacturersto conduct comparative effectiveness studies or an expansion of thefederal government's role in such studies).
* Encourage appropriate development of CEA so that as the privatesector increases its production and use of such analyses, both as anevaluation and a marketing tool, federal regulators and health carepayers can become "educated users and reviewers" of the data.
Copies of the 329-page OTA report can be ordered (cost: $20) fromthe Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA,15250-7974. Fax: (202) 512-2250. The stock number of the report is052-003-01389-4. n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.