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.
Reimbursement for diagnostics is not a cost driver, but self-sustainable to the health system. Government initiatives to implement a systematic process to test cancer patients for genetic markers are taking hold, on
grounds that this will improve health outcomes by focusing care on interventions most likely to work in individual patients.
For example, through the National Cancer Institute (NCI), France has initiated a program to test for current and emerging
biomarkers in lung cancer, colorectal cancer, and melanoma. The UK's Stratified Medicines Innovation Platform aims to improve
the environment for personalized medicines. Both programs were initiated based on a commitment under National Cancer Plans.
Nevertheless, a key point is currently lacking in these plans: a formal, transparent diagnostic reimbursement process. If
that exists, governments will be able to benchmark testing against the potential savings from superior response to treatment.
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 firstname.lastname@example.org