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Myriad Confronts Physician Questions on Cost, Utility as It Refocuses Vectra DA Sales Effort


NEW YORK (GenomeWeb) – When Myriad Genetics announced in February 2014 that it would acquire Crescendo Bioscience and its Vectra DA test for rheumatoid arthritis, it marked a significant moment for clinical proteomics.

The field had scored milestones including product launches and US Food and Drug Administration clearances but had (and still has) little to show for itself in terms of actual profits.

With its $270 million purchase of Crescendo, however, Myriad appeared to signal its belief that, at least in the case of the company's Vectra DA product – a 12-protein test for measuring RA disease activity – clinical proteomics, whatever its past struggles, held future promise.

One year later, though, Vectra DA revenue growth appears to have stalled. At the time of the acquisition, Myriad President and CEO Peter Meldrum said Vectra DA was on a revenue run rate of $10 million per quarter "and growing rapidly." Since then, the company has posted essentially flat Vectra DA sales of $10.8 million, $10.6 million, and $10.8 million in Q4 2013, Q1 2014, and Q2 2014, respectively.

On Myriad's Q2 2014 earnings call in February, Meldrum noted that based on 2014 H1 revenues, the company was well off its initial 2014 guidance of $65 million for Crescendo.

He added that under Crescendo President Bernard Tobin, who replaced William Hagstrom in December of last year, the company had developed a plan to "refocus" Vectra DA sales efforts, including "initiatives such as streamlining the Vectra DA ordering process for rheumatologists, implementing sales strategies similar to our successful protocol integration program first developed in the Preventive Care market, and employing practice management software tools."

Meldrum noted that the company did not anticipate a "significant inflection in Vectra DA revenues in the short-term," as the announced changes would "take some time to become effective."

The results indicate that Crescendo and Vectra DA are not immune to the challenges other proteomic tests – and molecular diagnostics more generally – have faced in securing payor coverage and driving physician adoption.

Indeed, a number of rheumatologists contacted by GenomeWeb in recent weeks expressed either disinterest in the test or a skepticism that it offered clinically actionable information beyond that provided by conventional markers like joint exams and c-reactive protein and erythrocyte sedimentation rate tests. And while such responses do not necessarily reflect on the merit of Vectra DA, they do highlight some of the challenges Myriad faces as it works to expand the product's customer base.

Andrew Gross, rheumatology clinic chief at University of California, San Francisco Medical Center suggested to GenomeWeb that research had not yet shown Vectra DA to offer a significant enough improvement over existing tests to justify its use, particularly given its relatively high price. Medicare reimburses for the test at $575.

"We have blood tests, the CRP and ESR, that are used to help us address disease activity [in RA patients]," Gross said. "They are well validated and are used as a part of calculation of disease activity scores. Any test beyond those, particularly ones that are at very high cost, we should look at very critically to decide whether to incorporate them into our daily practice."

Stanley Cohen, director of rheumatology at Presbyterian Hospital in Dallas and a professor at the University of Texas Southwestern Medical School, likewise told GenomeWeb that he felt Vectra DA's benefits didn't justify its costs, adding that he hadn't "found the [test] to provide additional information important to modify patient treatment for RA."

Crescendo and Myriad have "done a great deal of work demonstrating the test does correlate with disease activity, but with use of a routine labs [like] CRP and ESR and proper joint exams and patient histories, I don't think the extra cost associated with the test justifies its routine utilization," he said.

Cohen did note, however, that he thought the test could be helpful in certain cases where a doctor was trying to determine whether a patient's symptoms were due to active inflammation or previous damage.

He also said he thought it was a potentially interesting research tool. "For example, in early phase studies evaluating the impact of a new therapeutic, the Vectra assay may provide confidence of a biologic effect justifying continued [drug] development," he said.

Overall, though, Cohen said that he didn't "see the cost benefit for use in the clinic at this time."

Eric Sasso, Myriad's vice president, medical and scientific affairs, told GenomeWeb that he had encountered similar criticisms of the test. He suggested, though, that as physicians become more familiar with the clinical data surrounding the test and gain more experience using it in their practice, they come to better appreciate its usefulness.

"It's very easy to imagine how one might not want to make certain decisions on the basis of a [single] test alone, especially if the test hasn't been used [by a doctor] often enough to really understand what it offers and the variety of situations in which it may have a role," Sasso said. "Because it is in the end a piece of a puzzle. It's not meant to replace everything else that is done. It's to supplement it."

Regarding the belief that Vectra DA adds little information beyond that provided by existing measures like CRP and ESR scores, Sasso pointed to a study published last year in Arthritis Research & Therapy that found that in 9,135 patients with active RA, 58 percent had neither elevated ESR nor CRP; only 16 percent had both elevated ESR and CRP; and 26 percent had one but not the other elevated.

The findings, he noted, indicated that these measures likely fail to identify a large proportion of patients with active disease. However, active disease was determined in the study by use of the Clinical Disease Activity Index (CDAI), a measure using swollen joint counts and a physician global assessment that is also part of the traditional diagnostic toolbox for RA.

Sasso also cited a paper that he and other Crescendo scientists published in Current Medical Research & Opinion in 2013 that found that physicians changed their prescribed treatment plans for 38 of 101 patients after viewing their Vectra DA results.

This matches the experience of Olga Petryna, a rheumatologist at Beth Israel Medical Group inNew York City. Petryna, who told GenomeWeb that she orders Vectra DA for nearly all her RA patients to help her gauge their disease activity, said that she estimates the test leads her to alter her treatment plan for between 30 percent and 40 percent of her patients compared to the treatment she would have pursued based on conventional measures alone.

Used in concert with traditional methods, the test provides a fuller picture of a patient's RA activity, said Petryna, who has no financial connection to Myriad. She cited the AR&T study as an example of how CRP and ESR scores alone can lead a physician astray.

Additionally, she noted, the test is useful given the challenges of pinning down a patient's RA status given the subjective nature of the disease's symptoms and the frequent occurrence of overlapping conditions.

"For example," she said, "there are people who are not complainers who have a high tolerability for pain, and if I suspect that they might not be truly in remission it could help guide my therapy and let me be more aggressive in their treatment regimen. Often after a patient tries this more aggressive regimen they say, 'Now I feel the difference. I thought I was doing OK, but I was not.'" 

In other cases, Vectra DA can help identify if patients' pain as reflected in their CDAI score is coming from a condition like fibromyalgia as opposed to their RA activity, Petryna said.

The test "helps me be more objective in how I assess pain in RA patients and to be more proper in my management [of them]," she said.