WASHINGTON _ Managed care organizations (MCO)are keeping an arm's length relationship with drugcompanies, convinced that industry-sponsoredpharmacoeconomic studies are biased. But MCOs areequally distrustful of federal regulation of these studies,preferring instead that guidelines be developed by privategroups.

These are the key findings of a survey of 43 MCOs thathave performed or used pharmacoeconomic studiesconducted by drug companies. The survey was conductedby Jonathan Lax, president of The Marketing Auditconsulting firm, of Philadelphia, and Elizabeth Moench,president of the MediciGroup Inc., a King of Prussia, Pa.-based marketing research firm. The survey results werepresented last week at the FDA's public hearing onwhether the agency should become involved in regulatingpharmacoeconomic studies.

Many biotech companies are beginning to initiate cost-effectiveness studies in order to compete in the managedcare marketplace.

MCO's healthy mistrust of pharmacoeconomic studiesperformed by drug companies was cited often at the FDAhearing. Bryan Luce, CEO of MEDTAP Internationalconsultancy, Arlington, Va., referred to a recent study bythe San Francisco-based Zitter Group consultancy thatfound MCOs simply don't believe industry-sponsoredstudies and don't use them. Even cost-effectivenessstudies grounded in data from Phase III clinical trials areviewed as inadequate because they do not properly profilereal world utilization of drugs, said Alan Hillman,director of the Leonard Davis Institute of HealthEconomics, of Philadelphia.

Acutely aware that the FDA may step in and regulatetheir pharmacoeconomics studies as they do promotionalmaterials, the drug industry has issued two sets ofguidelines of their own. MCOs interviewed in the surveywere not aware that the industry had already written theirown guidelines to police themselves. (See BioWorldToday, Sept. 16, 1995, p. 1.)

"Lack of awareness of the industry's guidelines shows thegulf between MCOs and drug firms about the regulationof pharmacoeconomics studies," Moench told BioWorldToday.

FDA Regulation Unwelcome

However, MCOs and the drug industry are in agreementthat FDA regulation of cost-effectiveness studies wouldbe unwelcome and unwarranted. Only 18 percent of theMCO executives surveyed said they supported the FDA'sproposal to regulate pharmacoeconomic studies while 55percent said FDA involvement was "inappropriate."

A representative of the drug industry at the FDA hearingwas likewise convinced that the FDA should remain onthe sidelines and let the market set the rules forpharmacoeconomic studies. "If an MCO makes a badbuy, that's their problem and if they make enough ofthem, then they will learn from it. Furthermore if a drugcompany tried to peddle biased data, we would get firedby our customers and we would deserve it," said MitchDaniels, president of North American pharmaceuticaloperations for Eli Lilly and Co., of Indianapolis.

MCOs point to the need for flexibility in approaches tothese studies. They said that purchasers, manufacturers,and technology assessors need to have the flexibility toevaluate costs of products in different settings, withdifferent populations and from various vantage points.

MCOs said a private organization, such as the NationalCommittee for Quality Assurance, of Washington, whichis developing outcomes measures on the overallperformance of health maintenance organizations (HMO),should lead the discussion on the development ofguidelines.

That MCOs want to maintain control of cost-effectiveness studies was a constant refrain of managedcare executives interviewed in the survey. Most MCOsrely on literature surveys more than any other source forinformation about the outcomes and costs associated witha new therapy, said several presenters at the FDA hearing.

While some MCOs have pioneered partnerships with ahandful of drug companies, most are keeping a healthydistance from them. Managed care plans want to developtheir own studies but would look to drug companies forfinancial support and help in designing the study in "reallife clinical settings," according to the survey. The needto control the data was stressed repeatedly by the MCOexecutives.

Editor's note: Tuesday's BioWorld Today will include afollow-up report on the FDA's hearings about thesestudies, including a strategic overview on ways toimprove relationships with MCOs and how to make thestudies more effective. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.