Bridging the Hidden Hurdle in Cancer Cures - Pharmaceutical Executive


Bridging the Hidden Hurdle in Cancer Cures

Pharmaceutical Executive

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 proprietor.

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 budget holders.

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.


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