Improving the Dialogue

Below are four suggested messages that can serve as the starting point for any structured dialogue focused on a solution to the reimbursement challenge:

Diagnostics incentives support common goals among payers and industry. The current economic state leaves budget holders unsympathetic to the simple assertion that pharmaceutical companies should not pay for diagnostics; therefore, it is in industry's best interest to advance metrics that demonstrate the efficiency, cost, and outcomes benefits of targeted agents. Put bluntly, diagnostic agents are more effective and safer than chemotherapies, resulting in more efficient use of resources. In addition, there is a reduction in uncertainty that a patient will benefit from the treatment as demonstrated by higher response rates. And finally, these therapies improve patients' quality of life.

Targeted therapies facilitate more rapid adoption of clinical care and effectiveness guidelines. A key objective of all national health reform strategies is improving the pace at which professionally endorsed clinical practice guidelines are taken up and applied in actual practice. In the US, that often takes up to two decades. An effective, integrated reimbursement standard for diagnostics will ensure that clinicians know which guidelines to apply, and under what conditions. Presumably, this should again feed back to better outcomes—the ultimate objective of all guidelines, whatever the condition. A predictable diagnostics standard will in turn prompt more countries to draft guidelines that relate specifically to cancer. At present, only the US—through the National Comprehensive Cancer Network (NCCN)—has strong guidelines in place; even though cancer is firmly established as a global disease, there are fewer ground rules for the application of diagnostics internationally. Guidelines are also vital as a building block around methodologies for the cost-effectiveness studies now required by many countries as a condition for access. It is particularly important that because of their unique applications, diagnostics not be subjected to a "one size fits all' rule in application of these methodologies.

Reimbursement for diagnostics will enhance the role of neglected stakeholders in improving cancer care. For example, our industry has an unfamiliar advocate in the work done by the pathologist. Targeted therapies reliant on genetic testing have transformed the role of the pathologist to a key decision-maker in the treatment of cancer patients. In that regard, the industry has an advocate for not only facilitating testing, but also for reimbursement as they best understand the need for a process that increases the odds that patients will get tested for key genetic markers. Nurses and physician assistants also have a strong interest in improving access to diagnostics, as their intervention at this stage of the treatment continuum can reduce time and decision pressures on the withering ranks of specialists. Leveraging these groups' support is a crucial first step in improving conditions for reimbursement.

To conclude, what we hear is near universal support for the credo that personalized medicine is the wave of the future around enlightened patient care. Finding an effective pathway for the reimbursement of diagnostics—to end the uncertainty industry faces in providing good diagnostic tools to clinicians—is central to realizing that promise. Pfizer is committed to working with the patient, physician and payer communities as well as the diagnostic industry to carry this vision forward.

Don Creighton is Director, Oncology Market Access, at Pfizer. He can be reached at don.creighton@pfizer.com