Specialty Pharmacy

Group Purchasing Organization Expands Ability to Participate in Clinical Trials

Reprinted from the February 2007 issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

With the hope of bringing oncology drugs to market faster, one group purchasing organization (GPO) has formed a deal that will create a national clinical trial network.

Onmark, which is an Oncology Therapeutics Network (OTN) company, said on Jan. 10 that it was partnering with contract research organization Quintiles Inc. in the deal. The GPO is initially focused on widening the ability of its members in community-based oncology practices to participate in mainly Phase II and III clinical trials, says Kim Bergstrom, Pharm.D., chief clinical officer of OTN and clinical adviser to Onmark. It plans to expand to clinical trials in rheumatology at a later date, she adds.

While Onmark General Manager Clark Avery says that "there are a lot of clinical trial organizations out there," he contends that Onmark's approach is different. "We don't need another clinical trial management organization," he says. "We need experts in oncology, with existing relationships."

"Much of oncology research is done in academic research centers," says Avery. "The place where patients are versus where the research is done is not the same place." Plus, he says, "with 600 new cancer medications in development, this creates a lot of competition for patients." Once patients accrue to the trial faster, he says, this will either "get the product to market faster" or the manufacturer will reinvest its efforts on another product. He says that cancer therapy Gleevec (imatinib mesylate) is a good example: "They stopped the trial early and put all the participants on the therapy" because it showed such promise.

Avery says that Onmark brings its network of community-based oncologists — it now has 2,209 total member clinics and 3,792 total physicians — plus its relationship with these physicians and the ability to leverage its technology to the deal. Quintiles, on the other hand, offers "expertise, knowledge and training," he adds. As part of the deal, Quintiles will conduct on-site visits to Onmark members in order to train them in clinical-trial protocol compliance.

Onmark launched the network with a Phase III trial for a potential breast cancer treatment. Bergstrom says 80 practices expressed interest in participating. She adds that the GPO has announced four other trials since then. Overall, she says, "probably over 110 or 120 practices have been interested."

Many Physicians Likely to Be Early Adopters

Plans will benefit as physicians gain real-world experience with these drugs, says Avery, and "patients will have access to something that they would not get otherwise." He adds that with the early access to pharmaceutical products, many of these physicians will be early adopters of the therapies when they become commercially available.

"Physicians [in clinical trials] will certainly be more knowledgeable about the drugs," and more familiar with the education and training connected to them, says Debbie Stern, vice president of consulting firm Rxperts. But, she says, some newer therapies are not necessarily more efficacious than the older ones. She adds that off-label use of specialty pharmacy drugs, which is already a concern for payers, may also be impacted because "there may be potential pressure to cover the [newer] drug for off-label use."

Trial participants, she says, are "paid a lot of money" for their involvement, which is important to remember during a time when oncology reimbursement is on a downslide. "Oncologists are losing money right now. Any time that pharma is introduced back into the oncologist's office, this gets health plans nervous," she says.

Bergstrom, though, points to the oral oncology products coming onto the market. Just because they are oral, she says - which means that oncologists "will not be reimbursed for the drug when it becomes commercially available" (because oral drugs will be covered under the pharmacy benefit rather than the medical benefit) — "this is not a barrier to doing a clinical trial."

Another consideration is that community-based oncologists may not be "as savvy as academic-based clinicians," she adds. "There is a difference between training [someone to manage a clinical trial] and having a clinical researcher you employ on site who can handle potential problems and documentation."

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