Pharmacoeconomics influencing clinical trials earlier, says Cutting Edge Research

Increasingly, HEOR teams are playing a key role in how clinical trials are set up, according to new research from Cutting Edge Information, Inc. (CEI; Durham, NC). The study, “Health Economics and Outcomes Research: Aligning Clinical and Commercial to Meet Payer Demands and Win Reimbursement,” found that at 15% of large pharmaceutical companies surveyed, HEOR teams work closely with clinical trials.

While 15% may sound like a low number, it shouldn’t “since this trend has only recently emerged in full force,” says Michelle Vitko, senior research analyst at CEI. “[And] we do believe that more companies will incorporate their HEOR teams earlier in development to build outcomes research into their clinical trials.”

The reason for the trend has to do with reimbursement—and ensuring that the clinical trials will produce the data and analysis payers need to make favorable formulary and reimbursement decisions. “This is especially true if payers require certain endpoints for reimbursement—for example, if they want to see a specific analysis used or data for a certain subpopulation,” Vitko says. “If these endpoints are not incorporated early in the clinical trial, then additional trials may be need to be conducted later to gather this data—which can be costly and time consuming.”

The study, which analyzed quantitative and qualitative data from 30 pharmaceutical, biotechnology and medical device companies, also found that more companies are moving HEOR oversight to medical affairs, “away from the more commercially oriented pricing and reimbursement functions.” Another trend is the increasing use of patient-reported outcomes, ranging from 88% of companies surveyed in the European Union, Canada and Australia, 75% of companies in emerging markets to 55% of US companies. PROs

For more information or to purchase the report (#PH175), visit www.cuttingedgeinfo.