The Lynx Group

Predictive Testing Holds More Value to Oncology Stakeholders than Prognostic Testing

September 2014, Vol 5, No 7

Los Angeles, CA—Predictive testing offers greater value over prognostic testing to most stakeholders in cancer care, because it has a direct impact on disease treatment rather than simply predicting the course of the disease (which is, ironically, the role of prognostic testing), said S. Macey Johnson III, MBA, Vice President, Managed Care and Reimbursement, bioTheranostics, San Diego, CA, at the Fourth Annual Conference of the Association for Value-Based Cancer Care.

A prognostic test measures the risk for disease recurrence. It can be used with tumor positive or tumor negative markers. With this type of testing, “we’re not talking about driving a treatment decision or a particular medical intervention,” said Mr Johnson.

Examples of prognostic testing include BRCA testing to determine the risk for hereditary breast and ovarian cancers, and the Oncotype DX Colon Cancer Assay, which quantifies recurrence risk in stage II and stage III colon cancer (Table 1).

By contrast, predictive markers can be defined as a single trait or a signature of traits (ie, a single gene or a multigene panel) that separates different patient populations with respect to the outcome of interest in response to a particular targeted treatment.

“It’s about getting the right drug to the right patient at the right time,” Mr Johnson said. “Therefore, there should be cost-savings and synergies associated with employing this practice in the clinical setting.”

Predictive tests include the tests that identify HER2 or KRAS mutations that can predict the clinical benefit of specific targeted therapies, or the CancerTYPE ID test, which identifies primary tumor type in metastatic cancer and predicts response to extended endocrine therapy (Table 1).

In the case of CancerTYPE ID, the test is performed at year 5 for women who are estrogen receptor–positive and who want to determine if they should continue to receive endocrine therapy for years 5 through 10.

A predictive test may relieve a patient of the burden of receiving a treatment to which he or she will not respond, said Mr Johnson.

Triple Value of Predictive Testing
The value proposition behind predictive testing is the triple aim of improving outcomes, improving the patient experience, and reducing or controlling the overall cost. Health economics models show that predictive testing can indeed control costs, with cost offsets.

“Patient experience can vary, because in some situations, the patients certainly will have the information and knowledge, but the experience may not be as positive if you are at extremely high risk for a certain disease state and you are a nonresponder to the best-in-class drug,” Mr Johnson noted.

In prognostic testing, improving and standardizing outcomes are much more difficult. “Some would argue it doesn’t exist at all,” said Mr Johnson. “The patient experience, though, can often be enhanced.”

Patients who know that their risk for a certain disease is low or high, for example, can empower themselves to better make decisions about how and how often to use the healthcare delivery system.

Prognostic testing falls short of predictive testing in controlling costs. “There’s typically no direct return on investment, not a direct return, or cost offset with the prognostic test,” Mr Johnson pointed out.

Payers and regulators tend to be skeptical of prognostic-only testing, because of the lack of perceived clinical utility or “actionability” (Table 2).

Advanced Diagnostic Tests
Diagnostic testing has traditionally failed to capture its fair share of value in the healthcare system. “With the complexities of the data sets that are being developed, I think this is even going to continue to manifest itself, at least until some of the reforms hit in 2016,” Mr Johnson advised.

Diagnostic testing is estimated to influence 70% of the decisions made by US physicians, yet only 2% of the $2 trillion spent annually on healthcare flows to diagnostic providers. “The value proposition still has a long way to go in terms of the overall industry,” he said.

The future of capturing the value of diagnostic tests may lie in a new bill (H.R. 4302). A key component of this bill is the creation of a new type of testing known as “advanced diagnostic tests” or “laboratory-developed tests” (LDTs).

Advanced diagnostic tests include (1) a multianalytic assay with an algorithm, and (2) tests approved by the FDA. Under the second type, many of these tests will switch from a CLIA (Clinical Laboratory Improvement Amendments) pathway, with a regulatory perspective, to an outright FDA-approval pathway.

For the new advanced diagnostic tests, the payment rate for the first 3 quarters will reflect the laboratory’s actual list charge, and, thereafter, payment rates will be based on payer data reported by the laboratory. It will require the Centers for Medicare & Medicaid Services to establish an advisory panel to provide input on payment rates for new tests and the factors used in determining coverage and payment processes for new tests.

The BRACAnalysis test is one of the first LDTs submitted for FDA premarketing approval. “I can assure you it’s not going to be the last,” said Mr Johnson. “You’re going to see many LDTs now rethinking their overall business strategy due to the new bill that has recently been passed,” he noted.

The goal is to obtain a permanent Current Procedural Terminology® code for the test, instead of continually billing under a miscellaneous code, which would improve efficiencies for payers, manufacturers, and developers.

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