WASHINGTON _ More and more biotech drugmanufacturers are contracting with technologyassessment groups to make sure that when their productsare ready for marketing, each advertisement andmarketing promotion will be backed up with a study todocument the drug's cost effectiveness.
Completing such assessments is becoming increasinglycomplex. Manufacturers not only must anticipate how toclear the hurdles raised by managed care plans todocument the effectiveness of their drugs but they alsomust consider how to deal with the FDA, which isconsidering whether to regulate pharmacoeconomicstudies.
The FDA will continue to explore if and how it shouldregulate pharmacoeconomic studies at a public hearingthis week. It will focus on the changing audience forinformation supplied by the drug industry, specifically theagency's role in monitoring such information.
This will be the second FDA public hearing on this topic,which may rank as one of the drug industry's worstnightmares. The first hearing was held last March to air adraft FDA policy statement on principles for theregulation of cost-effectiveness claims in promotionalmaterials. (See BioWorld Today, March 27, 1995, p. 1.)
A drug company has to design its pharmacoeconomicstudies with two constituencies in mind: managed carefirms and employers, said Alan Hillman, director of theLeonard David Institute of Health Economics, Universityof Pennsylvania.
"If drug companies are going to sell to managed careplans, they need to understand that they value therapiesthat are important to their clients: business. Employerswant their workers back to work quickly, to pay for theminimum of days of hospitalization, make fewexpenditures by employee assistance plans, and havehealthier, more productive employees."
Managed care plans look for the same attributes oftherapies but they also look carefully at "me-too drugsand manufacturers who offer value added services," saidHillman in an interview with BioWorld Today.
These value-added services typically include diseasemanagement programs that help hospitals and physicianstreat patients with serious illnesses using a case-management approach that reduces inappropriate orunnecessary care.
How To Buy A Good Study
Sorting out the attributes of pharmacoeconomic studies innot necessarily clear. So far, two sets of guidelines haveemerged that seek to instill some order in the unstructuredfield of cost effectiveness research. Both guidelines havebeen funded by the drug industry.
The first set of guidelines was developed by thePharmaceutical Research and Manufacturers of America(PhRMA). A second was developed by the University ofPennsylvania with grants from drug manufacturers who"did not impose any influence on the money or theprocess," said Hillman.
The University of Pennsylvania guidelines, published inthe July 1, 1995, Annals of Internal Medicine, werewritten by a group of academics, representatives of drugfirms and managed care plans and health researchers.
Drug companies have a vital interest in funding thedevelopment of guidelines that seek more structuredrelationships between manufacturers and researchers inlarge part to enhance the credibility of the research thatthey fund.
How useful these industry sponsored guidelines will behas already been cast in doubt in an editorial thataccompanied publication of the guidelines in Annals.
"Most of the . . . recommendations essentially say thatthose who undertake economic analyses of technologyshould do good and abstain from evil . . . But in the end,they offer procedural solutions to what is fundamentally astructural problem. The sponsors have a large economicinterest in research outcomes and the researchers haveprofessional and economic interest in doing research.Bias is inherent in such a structure. Telling each party tobe good may be of limited usefulness," according toRobert Evans, director of the population health program,University of British Columbia, Vancouver.
The business of pharmacoeconomics is lucrative fortechnology assessment firms. Hillman estimates that 200to 300 drugs currently are undergoing pharmacoeconomicassessments. "Forty percent of these are being performedby consulting firms that don't know what they are doing;20 percent by ones that do, with the rest split evenlybetween qualified and unqualified academics," he said.
How does a drug manufacturer inexperienced incontracting for pharmacoeconomic studies find aqualified research group? Hillman listed a number ofattributes. "Check to see if they meet the guidelinespublished in Annals, sit on academic committees, havebeen invited to testify before Congress, have consultedwith the FDA and have published articles in peerreviewed journals."
The FDA's possible entry into the rapidly evolving fieldof pharmacoeconomics may prove to be the "wild card,"for many manufacturers, said Hillman. Not only mustmanufacturers make sure their pharmacoeconomic studiesmeet the needs of managed care firms but they also mustcollect data that the FDA may demand." n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.