The struggle to make cancer a curable condition depends not only on good science, but customized treatments that address the
range of genetic aberrations responsible for uncontrolled cell growth. In fact, if the concept of "personalized medicine"
is to apply anywhere, it must first start with the practice of oncology. Realizing this promise has its challenges, the most
important of which is incorporating the latest diagnostics tools in the continuum of patient care, at a cost that is appropriate
for the innovator and acceptable to payers, patients, and society at large.
Specifically, what we are confronting is a new "access hurdle" that comes right after the long process of market authorization
is completed. It's best posed as a question: How can you build an effective, responsive price and reimbursement standard to
establish that there is sufficient incentive for industry to develop the diagnostic tests that ensure the right patients will
benefit from the best drug for their condition?
By and large, reimbursement of diagnostics is an opaque and passive process, in contrast to its pharmaceutical counterpart,
where there is a relatively transparent pathway to a price agreement. The lack of such an approach for diagnostics leads to
a lengthy process by which diagnostic and pharmaceutical companies are obliged to determine if a structure exists for reimbursement
via a code-based system or coverage through hospitals or labs. In the latter case, there can be a high degree of budget variance
across institutions. Hospitals and labs with insufficient funding are compelled to make tradeoffs on the number of patients
that can be diagnosed appropriately. Rules also differ on stakeholder engagement in soliciting for diagnostic reimbursement.
In some cases, the pharmaceutical industry is prohibited from involvement.
Ultimately, the lack of clarity and systemic gaps lead to a lag in access, which has an impact on all key stakeholders. Patients
receive suboptimal diagnoses and treatments given that physicians (oncologists, pathologists, etc.) lack metrics to showcase
the best clinical option. Payers are using resources inefficiently as funds may be spent on treatments with lower response
rates. One of the key criticisms of the oncology profession from payers is the "whatever sticks to the wall" ethos in determining
the course of treatment, which, given the high cost of most cancer drugs, is simply an admission that there is waste in the
system. Why not acknowledge that innovators of both the drug and diagnostic are not provided the appropriate incentives that
should come with investment in the development of effective, targeted therapies?