Adopting New Medical Technology (1994) / Chapter Skim
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12. MANUFACTURER'S RESPONSES TO THE INCREASED DEMAND FOR OUTCOMES RESEARCH
12. MANUFACTURER'S RESPONSES TO THE INCREASED DEMAND FOR OUTCOMES RESEARCH
Pages 152-171
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From page 152... ...
Simply stated, the technology assessment trend emphasizes the importance of considering comparative effectiveness and relative value in evaluating medical technologies. But the application of this concept varies considerably among providers, payers, and regulators and over time-creating uncertainty on the part of manufacturers as to precisely what sorts of information will be required as the technology assessment trend matures.
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From page 153... ...
. Patient outcomes research extends beyond the safety and efficacy studies traditionally conducted by pharmaceutical companies.
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From page 154... ...
The challenges of patient outcomes research lead clinical researchers to expand their scope of clinical methodologies and techniques. For example, the limitations of randomized, controlled clinical trials (RCTs)
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From page 155... ...
medical device industry comprises roughly 7,000 manufacturers whose varied outputs include mundane commodity products such as tongue depressors and surgical masks, expensive capital equipment such as gammaradiation sterilizers and magnetic resonance imaging scanners, high-technology singleuse products such as percutaneous transluminal coronary angioplasty catheters 3 This chapter utilizes information obtained through 23 interviews with representatives of 15 manufacturers and 4 consulting or research organizations. To ensure the anonymity of interviewees and their companies, only publicly disclosed examples of manufacturer outcomes research activities are cited specifically.
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From page 156... ...
for the beneficiary? The fact that payers answered these questions by conducting their own technology assessments sent two clear messages to the involved device manufacturers.
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From page 157... ...
Because a limited number of new medical devices face these issues, the pool of device manufacturers who conduct outcomes research is rather small and quite sophisticated compared with the broader population of device manufacturers. These "high-tech" device manufacturers have tended to sponsor prospective controlled clinical trials, typically focusing on patient outcomes.
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From page 158... ...
Device companies almost always commission outside researchers to run the clinical trials associated with their outcomes research, largely because they do not have the extensive clinical research infrastructures found in pharmaceutical companies. But device companies also emphasize research credibility as an important reason for commissioning independent researchers.
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From page 159... ...
However, most pharmaceutical firms did not begin to think seriously about outcomes research until the 1987-1989 time frame. By then the increasingly restrictive practices of hospital, HMO, and Medicaid formulary committees had forced pharmaceutical companies to address directly the issue of value with their customers.
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From page 160... ...
In most companies, the outcomes research function is still quite protean and will continue to evolve over the coming years (Freeman, 1991; Steward, l991a,b, 1992; The Zitter Group and Technology Assessment Group, 1992~. Although the very early outcomes research efforts of pharmaceutical companies focused on patient outcomes, recent emphasis has shifted to economic outcomes.
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From page 161... ...
There is a significant degree of disagreement among knowledgeable parties regarding the usefulness, validity, and limits of the investigational methodologies and instruments that are being employed in the service of outcomes research. Most pharmaceutical firms produce a mix of prospective studies, retrospective analyses, and economic and decision-analytic modeling.
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From page 162... ...
In some pharmaceutical firms, those who are involved in the outcomes research function operate primarily as consultants to those who are involved in the clinical R&D functions, who then run the studies (particularly when studies are of investigational compounds and are incorporated into the clinical development program)
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From page 163... ...
Despite some differences in how pharmaceutical firms approach outcomes research, a number of clear trends can be identified. Pharmaceutical companies are initiating outcomes research earlier in the product development cycle, conducting it for more compounds, and using prospective study designs more often.
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From page 164... ...
In comparison with traditional pharmaceutical firms, however, biotech companies have not been very active in outcomes research. This may be because biotech firms are typically more technology driven and less market oriented than traditional pharmaceutical firms.
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From page 165... ...
Indeed, Synergen's efforts rival those of the large, traditional pharmaceutical firms and will probably serve as a model for other biotech companies. Summary Observations It is evident from the foregoing discussion that manufacturers' outcomes research is market driven.
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From page 166... ...
The fact that many biotech companies are only now beginning to recognize this rationale for outcomes research does not make it any less clear. By contrast, traditional pharmaceutical firms, whose products rarely embody the biotech extremes of high cost and radical innovation, face more subtle and diffuse market forces.8 It is interesting to note, therefore, that traditional pharmaceutical firms have taken the lead in outcomes research.
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From page 167... ...
However, with the exception of studies conducted by AHCPR-sponsored Patient Outcomes Research Teams, there has been little comprehensive outcomes research conducted on clinical conditions or on noninvestigational, non-product-driven medical procedures. Much more work of this sort is needed if the emerging body of outcomes research is to provide an adequate basis for improving patient care and .
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From page 168... ...
the increased expense of outcomes research, viewed as a percentage of total product development costs, is considerably higher for high-tech device companies than for pharmaceutical companies, and (2) unlike the pharmaceutical industry, the high-tech device industry includes a significant number of relatively small companies, which makes the device industry more sensitive to competitive shifts in the requisite critical mass.
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From page 169... ...
Investment in outcomes research can be used to create barriers to entry in specific markets, particularly in markets for pharmaceutical therapies that treat chronic conditions. This is because key decisionmakers show keen interest in outcomes research on the comparative impact of pharmaceutical therapies on endpoints such as survival and disease progression in patients with chronic diseases; but such studies can take 5 to 15 years, require thousands of patients, and cost millions of dollars.
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From page 170... ...
The information generated by outcomes research has real potential to improve patient care and help rationalize health care expenditures. Of course, as discussed above, realizing this potential requires that (1)
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From page 171... ...
1982. Strategies for Medical Technology Assessment.
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