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Myriad’s UHC Contract for myRisk Offers Patients Tested on Older Dx Chance to Get NGS

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NEW YORK (GenomeWeb) – Myriad Genetics is hoping that its recent coverage deal with national payor UnitedHealthcare for its next-generation sequencing myRisk Hereditary Cancer panel will offer a blueprint for other payors to follow suit.

During an earnings call this week with market analysts, Myriad CEO Peter Meldrum called the deal with UHC, the second largest payor in the US, a “transformational” contract. He highlighted that not only does the contract allow UHC enrollees who meet certain eligibility criteria to gain access to myRisk, but the terms of the deal also offer those who have previously been tested by Myriad’s first-generation risk diagnostics to be retested by the more advanced NGS panel.

The myRisk test gauges 25 genes associated with eight hereditary cancers, including breast, colon, ovarian, endometrial, pancreatic, prostate, and gastric cancers, and melanoma. Myriad launched myRisk last September through an early access program and in February started a marketing push to recruit more physicians to use the diagnostic. As of March, Myriad has been making its myRisk sales pitch to oncologists across its genetics segment.

During the third quarter of fiscal year 2014, MyRisk brought in $14.5 million in revenues. BRACAnalysis and the BRACAnalysis Large Rearrangement Test together still comprise the bulk of Myriad’s product revenues, contributing $140.8 million out of $176.2 million the company reported during the quarter in molecular diagnostics sales.

Mark Capone, president of Myriad Genetic Laboratories, said that he expected there to be “meaningful increases” in myRisk revenues beginning in the fourth quarter. The company is hoping to fully commercialize the test this fall and subsequently phase out all its hereditary cancer testing and transition completely to the panel by summer of 2015.

In the meantime, Myriad is planning to build the evidence base around myRisk and present a strong case for reimbursement to government and private payors. The company has submitted for publication two pivotal prevalence studies and completed two clinical utility studies. At the American Society of Clinical Oncology’s annual meeting in June, Myriad will have six presentations on myRisk.

At the San Antonio Breast Cancer Symposium in December, Myriad presented data from a large prospective study that found that its myRisk Hereditary Cancer panel was able to identify 51 percent more patients with a heightened risk for familial breast and ovarian cancer compared to testing just the BRCA1 and BRCA2 genes. Previously, the firm had shown that the myRisk test picked up 61 percent more patients at risk for hereditary colon cancer compared to standard genetic testing for the disease.

“With the 50 percent to 60 percent increase in sensitivity that we've seen with the myRisk test, we have certainly seen an increasing level of interest from healthcare providers to contact those patients that have been historically tested, and particularly those that had initially been identified as higher risk,” Capone said. “So, we think, over the coming months … we will see physicians reach out to some of those legacy patients and provide them the opportunity for updated testing.”

Noting that the UHC contract allows for patients previously tested on older Myriad hereditary cancer risk tests, such as BRACAnalysis and Colaris, to be re-evaluated on myRisk, Capone estimated that this represents a market potential of 1 million patients. Furthermore, the UHC arrangement is locked in at three years and cannot be terminated by either party. “This provision gives both companies pricing stability for an extended period of time,” Capone said, but he wouldn’t reveal details about the exact reimbursement price Myriad is receiving from UHC for myRisk.

The list price for myRisk is approximately $4,000. Based on economic models Myriad has conducted, company officials tout that the additional accuracy of myRisk can save $2,600 per patient.

Several times during the call, Myriad officials hinted to investors and analysts that payors have expressed interest in the myRisk test because the firm is offering a “substantial increase in information” at no additional cost. Medicare reimbursement for BRACAnalysis, after CMS’ recent revision to the CPT code describing full sequencing of the BRCA1/ 2 genes, stands at around $2,200, plus $500 for large rearrangement testing (i.e. BART).

In anticipation of full commercialization of myRisk this fall, Myriad is expanding its lab operations, ramping up training to its sales force, and bolstering customer service capabilities. The company has also been working to make its lab processes more efficient, so that it can offer faster turnaround times for its NGS test results than competing labs.

Capone announced during the call that the majority of myRisk test results are being returned to doctors in under two weeks. This 14-day timeframe is critical, particularly if a physician is considering surgical options for a particular patient, he added.

Myriad’s push to commercialize myRisk is occurring as the company is starting to face competition in the hereditary cancer space. Myriad felt the impact from other companies marketing their hereditary cancer tests and panels most readily in its oncology segment, which comprises 15 percent of its business.

“We believe our increased selling efforts into this channel, as well as the introduction of myRisk, will stabilize our future market share,” Capone said. “Our goal is to convert our payor contracts to myRisk with longer-term durations, as we have demonstrated with UnitedHealthcare.” He further noted that the recent passage of a bill that will convert Medicare pricing of lab tests to a market-based model by 2017 will also bring payment stability in the molecular testing market.

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