WASHINGTON _ Amgen Inc. is working with sixmanaged care plans to develop health economic analysesthat will maximize the use of Epogen and Neupogen.Partnering with the plans will give Amgen the kind ofinformation "we need to try to understand how thesedrugs are being used in actual practice," and optimizetheir use, said Bill Carter, manager of Amgen'spharmacoeconomic clinical services.

"By [voluntarily] implementing these Phase IV studies _those implemented after a drug is approved for marketingby the FDA _ the company will be able to establishbenchmarks of practice that can be measured against thelabeling. These benchmarks in turn can be used by otherorganizations that are developing medical practicestandards against which everyday practice decisions canbe evaluated," Carter said.

At present the FDA does not require cost-effectivenessstudies.

Thousand Oaks, Calif.-based Amgen's partnering effortswith managed care firms are clearly part of a trend. In1988, only 2.6 percent of all clinical trials involved healtheconomic analyses. In 1994, the figure jumped to 30percent, according to the Pharmaceutical Research andManufacturers of America.

Carter sees collaborative outcomes research withmanaged care plans as the wave of the future for biotechmanufacturers. "Biotech firms have to demonstrate thevalue associated with their products. They need to doconsiderable hard work beyond the efficacy studies."

Carter said that partnering with a variety of health careorganizations is the most effective means to "maximizepatient care and quality of life outcomes." Amgen isworking with several managed care plans includingindividual practice associations, closed panel healthmaintenance organizations and preferred providerorganizations.

Having medical practice protocols and outcomes analysesclearly gives Amgen a competitive edge. Amgen's healtheconomics studies have paid off by beating out thecompetition, said Jim Smeeding, associate director of theCenter for Pharmacoeconomic Studies, College ofPharmacy, at the University of Texas in Austin.Smeeding, who has assisted a number of biotech firms indeveloping cost-effectiveness studies, said, "I've been inmeetings where a group purchasing organization pickedAmgen's higher priced drug because of the value addedservices that Amgen provides.

"Amgen was one of the first firms to perform outcomesresearch and pharmacoeconomics to show the benefits ofits agents," said Smeeding.

Demonstrating Cost And Value

Pharmacoeconomic studies increasingly are beingdemanded by managed care plans that want to know thetotal cost of a therapy and its relative value compared toother therapies before incorporating it into practice.

However, because managed care plans have often beenskeptical of pharmacoeconomic studies sponsored bydrug makers, several manufactures have elected to partnerwith the plans to develop jointly sponsored analyses thathave more credibility.

Amgen's pharmacoeconomic studies are in many wayssimilar to the large outcomes projects funded by thefederal government since the late 1980s. These PatientOutcomes Research Teams (PORT) scan a number ofdata sources _ from medical charts to published peer-reviewed medical journals _ for evidence that onetherapy is more effective than another.

Amgen is likewise working with several universities thathave had experience performing outcomes research toadminister the often difficult and expensive datacollection and analyses, Carter said. Outcomesresearchers review medical charts because they yieldmore specific clinical information than could be obtainedfrom claims data, explained Carter.

An integral issue for managed care firms weighingincorporation of an expensive new drug therapy is if itimproves the quality of life of patients. However,quantifying improvement in quality of life is difficult inoncology where off-label and nonstandard treatmentprotocols are common.

"Like most therapies used in oncology, there isconsiderable variation in the use of Neupogen. Definitivecare is just not available in most tumor types," saidCarter. "Amgen wants to look at what is consideredstandard therapy today as well as what protocols arebeing developed by consensus panels. "The quality of lifeissues are more clear-cut for patients who have end-stagerenal disease," Carter said.

One way Amgen is measuring how Epogen contributes toimproved quality of life of end-stage renal diseasepatients is through a disease-specific quality of lifequestionnaire _ a variation of the SF-36 that has been inuse for several years. This health status survey measures,among other things, the patient's assessment of howmany activities of daily living are limited by the disease,amount of pain, and emotional well-being. n

-- Michele L. Robinson Washington Editor

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