A Heavy Burden
There is the option to rely on subsidization of diagnostics development costs by pharmaceutical companies to address the funding
gap. However, this is not a solution for the long-term because there are inherent complications to relying on one stakeholder
to shoulder the weight.
First, there are legal issues in many countries outside the US, where drug-maker subsidization is considered to be a "promotional
activity." Second, other key stakeholders needed to make the system work effectively—such as pathologists and laboratory technicians—have
differing preferences as to the type of platform used to identify a genetic marker. Third is the issue of fairness or equity.
Within oncology, some diagnostics used to test for genetic markers are covered, while others are not. There is no clear rationale—and
certainly no standard—to address this discrepancy. In addition, diagnostics in other therapy areas including CVD, diabetes,
and HIV are commonly covered, so why not do the same in the cancer space? Fourth, there may be multiple relevant treatment
options—adhered to by different pharmaceutical companies—for the disease identified; how can these be reconciled where there
are competitive circumstances at play? Fifth, expecting drug companies to do all the heavy lifting in subsidizing diagnostics
serves as a disincentive for them to invest more in the targeted therapy itself. This is particularly true now that science
has advanced to the point where new diagnostic tools are coming on stream that may not be under the control of a sole diagnostic
This last point is very important—and is best illustrated by the introduction of the multiplex ligation-dependent probe amplification
(MLPA) technique, more commonly known as multiplex. Multiplex allows multiple genetic markets to be tested simultaneously.
While this process may facilitate more efficient identification of genetic aberrations, it further clouds the reimbursement
picture. Multiple probes—very possibly owned by different diagnostic companies—will be used for a single test. Without a third-party
mechanism or other clear funding apparatus in place, the reimbursement process becomes very convoluted for the end users and
So the need for action is clear. As diagnostics reach a critical mass in oncology there is opportunity to work in partnership
with payers and other stakeholders to develop systems to expedite what is the bottom line for clinicians and patients: better
access and reimbursement. There are many good reasons for doing so. It is up to the industry to articulate them, particularly
now that regulators such as the FDA and European Medicines Agency (EMA) are beginning to engage in areas that directly impact
market access issues around diagnostics.