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MDx/CDx Focus: Myriad's Prolaris Initially Denied by Noridian; Life Tech's Pervenio Lung Cancer Dx


Medicare Contractor Uncertain About Covering Myriad's Prostate Cancer Aggressiveness Dx

Noridian, a Medicare administrator in Utah, said this week that it will list Myriad Genetics' Prolaris prostate cancer test on its draft non-covered local coverage determination list and solicit public comments on the test before making a final payment determination regarding the diagnostic.

Myriad markets Prolaris as a risk-stratification tool that can help doctors gauge whether prostate cancer patients are at risk of disease recurrence in a span of ten years. The test analyzes the expression of 46 genes, includes genes involved in how prostate tumor cells divide and replicate. If Prolaris determines that a patient exhibits low expression of these genes then they are considered to be at low risk of prostate cancer progression, while those with high expression are thought to be at high risk of disease recurrence and need more aggressive treatment. The test can also identify the subset of patients who are at "intermediate" risk for recurrence and should be closely followed.

During the public comment period for Noridian's draft LCD on Prolaris, "Myriad will review [the preliminary determination] with Noridian to underscore the role of the test as a molecular staging diagnostic that guides therapy for prostate cancer patients," the company said in a statement. Myriad will also "provide additional clarity on how the test is currently being used for medical management of patients with prostate cancer." After publication of its draft LCD document, likely next week, Noridian will accept public comments for 45 days.

Myriad has reported data from four clinical studies involving around 1,500 patients showing that the Prolaris test can accurately assess whether a man's prostate cancer is aggressive or indolent. "At diagnosis, Prolaris was the strongest single predictor of prostate cancer specific mortality," the company said in a statement.

Approximately 240,000 men are diagnosed with prostate cancer in the US each year, and because there is currently no standardized method for determining the aggressiveness of the disease, the vast majority of patients receive aggressive treatments that cause serious side effects. With molecular diagnostics, such as Prolaris and a similar prostate cancer aggressiveness test under development at Genomic Health, test developers are hoping to improve physicians' ability to avoid aggressive treatments in those at low risk of recurrence.

In a note to investors, Goldman Sachs analyst Isaac Ro wrote that based on past precedent, the initial determination may not end up as a coverage denial for Prolaris, and assured that the reimbursement discussions have no impact on Noridian's ongoing reimbursement process for Myriad's BRACAnalysis breast and ovarian cancer susceptibility test. "While this decision came as a slight surprise, Noridian has initially issued non-coverage status to a vast majority of molecular tests in the past only to reverse position and grant coverage following the comment period," Ro wrote. "We believe today's announcement merely highlights the lengthy nature of the reimbursement process and continued need for Myriad to spend on the development and commercialization of its pipeline."

Noridian's draft LCD on Prolaris reflects a desire on the Medicare administrator's part to see data supporting analytical validity, clinical validity, and clinical utility when assessing reimbursement for new tests. "We believe the first two items have been well established while the third will be the focus during the comment period," Ro noted. "We expect current physician users of Prolaris to submit comments supporting the clinical utility of this test." Myriad also has data from a recently completed Phase IV trial involving 300 patients that it might highlight in terms of showing to Noridian how Prolaris impacts physicians' treatment decisions, Ro added.

Like Noridian, Medicare contractors through the US are paying more attention to the clinical utility aspect of molecular diagnostics when determining coverage policies and setting payment rates. For example, CMS has charged Medicare contractor Palmetto GBA to launch its MolDx program, under which labs must submit data on the analytical validity and clinical validity and utility of their tests in order to receive Medicare coverage. Based on the clinical evidentiary data submitted by labs and the utilization information gathered by Palmetto, the contractor will determine CMS's reimbursement policy and pricing for molecular diagnostics performed in six US states and territories (PGx Reporter 11/16/2011).

Analyst Jon Wood of the investment firm Jefferies projected in a note to investors that Prolaris would net $2 million in revenue in fiscal year 2013, without "any reimbursement traction." Noting that more than 50 percent of new diagnostic tests are placed first in the draft non-covered LCD list, Wood highlighted that Genomic Health's Oncotype DX breast cancer recurrence test was on a regional Medicare contractor's non-covered LCD list from January 2004 to February 2006.

"While GHDX's experience could serve as a relevant procedural proxy, it does not necessarily imply a two year reimbursement delay for Prolaris, as Myriad has far more clinical and analytical data available than GHDX had in 2004," Wood wrote.

Life Technologies Launches Pervenio to Gauge Recurrence in Early-Stage Lung Cancer Patients

Two months after acquiring molecular diagnostics firm Pinpoint Genomics, Life Technologies has launched a multi-gene expression lung cancer prognostic test developed by the subsidiary.

Life Tech this week announced the availability of Pervenio Lung RS – a quantitative PCR-based assay that gauges the expression of 14 genes – through its CLIA lab in Sacramento, Calif. The test, developed by Pinpoint Genomics, analyzes formalin-fixed, paraffin-embedded tumor specimens and assesses the expression of genes associated with lung cancer progression, such as KRAS, BRAF, EGFR, HER2, ALK, and p53.

Earlier this year, researchers from Pinpoint and elsewhere published data in The Lancet from two retrospective studies involving 1,500 early stage, non-squamous, non-small cell lung cancer patients, and found that Pervenio "reliably identified" those at heightened risk of death due to their disease (PGx Reporter 7/28/2012).

Lung cancer patients have the worst mortality rates among cancer patients in that nearly half of early-stage lung cancer patients don't live beyond five years. Even after surgery to remove the tumor, lung cancer patients face a mortality rate of 25 percent to 65 percent.

Life Tech estimated the size for a molecular prognostic test for early-stage lung cancer patients to be around $120 million in the US and $500 million in worldwide.

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