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Draft LCD Limits Myriad Prostate Cancer Dx Coverage to Low-Risk Patients, Requires Training Docs

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Originally published Oct. 17.

NEW YORK (GenomeWeb) – A draft local coverage determination (LCD) issued by Medicare contractor Palmetto GBA for Myriad Genetics' Prolaris prostate cancer test proposes to reimburse the test for patients at low risk of disease progression who are expected to live for a decade or longer.

Specifically, the draft LCD issued this week proposes to cover the test for patients who are at "very low" or "low" risk of disease progression by Gleason score and prostate specific antigen testing. Additionally, patients must have localized adenocarcinomas with no evidence of metastases or lymph node involvement. While patients must be a candidate for conservative management to receive covered testing, based on Prolaris results they could receive more aggressive treatment, such as radical prostatectomy, radiation therapy, or brachytherapy.

Prolaris gauges the expression of 45 genes and assesses prostate cancer patients' risk of disease progression. Based on Palmetto's coverage criteria, Myriad estimated that approximately 50 percent of the prostate cancer population in the low or very low risk category would be covered for Prolaris testing.

Myriad, however, developed Prolaris as a multi-gene expression test that can assess whether patients are at high and low risk of progression, and as such, the preliminary LCD is likely narrower than the company was angling for.

There are a number of studies in which Myriad has shown Prolaris' ability to more accurately determine whether prostate cancer patients are at high risk or low risk for the disease. For example, researchers from the University of California, San Francisco and Myriad published a study last year in the Journal of Clinical Oncology, which analyzed samples from 400 men who had undergone a radical prostatectomy. In the published study, researchers reported that 100 percent of the men whom Prolaris deemed to be at "low risk" of progression did not experience a recurrence within the five years the study was ongoing. Meanwhile, 50 percent of those the test deemed to be at "high risk" did experience recurrence during that time.

In order for Medicare to reimburse Prolaris for high-risk or intermediate-risk patients, Palmetto said it will need to see the test included in "widely accepted" treatment guidelines by a body like the American Society of Clinical Oncology or the National Comprehensive Cancer Network. Alternatively, noting that the clinical validations studies on Prolaris have been retrospective in nature, Palmetto said Myriad will need to show that its test improves patient outcomes "through published prospective or prospective-retrospective trials."

"Prolaris is very important for the treatment of very low- and low-risk patients. However, the body of published evidence on the clinical validity and clinical utility of Prolaris supports its use in men with localized prostate cancer from all risk categories (low, intermediate, and high)," Myriad spokesperson Ron Rogers told PGx Reporter. "We will continue to work with MolDX and Noridian via the comment periods to provide further details."

The LCD was issued by Palmetto under its MolDx program, through which the contractor evaluates clinical validity and utility of molecular tests and determines Medicare coverage policies. The Medicare contractor that administers coverage benefits for Myriad's tests is Noridian. In Oct. 2012, Noridian informed Myriad of its decision to not cover Prolaris.

Since then, Myriad has provided CMS additional data on Prolaris' clinical utility, trying to tip the agency toward a positive coverage decision. For example, the firm presented interim results from the PROCEDE 500 clinical utility study earlier this year, which surveyed 150 physicians about how Prolaris influenced their treatment strategies for more than 300 prostate cancer patients. The study revealed that physicians chose to reduce their level of treatment and manage 40 percent of patients more conservatively based on Prolaris results. For 25 percent of cases, the test results spurred doctors to ramp up their intervention to performing surgery or treating patients with radiation. Doctors didn't change their treatment plans based on test results for 35 percent of patients.

However, under the draft LCD, physicians must undergo training before being able to order the test and receive Medicare reimbursement. According to Palmetto, physicians must enroll in a certification and training registry (CTR) program as a way to ensure that they are testing the right patients on Prolaris and Myriad is following patients to ensure that the benefits of testing outweigh the harms.

Myriad must, under the LCD framework, ensure that only doctors trained as part of the CTR are ordering testing; maintain a secure registry of CTR providers; and report utilization data according to clinicopathologic staging. Similarly, Palmetto's LCD for MDxHealth's ConfirmMDx prostate cancer test also required ordering physicians to enroll in a CTR program.

"Myriad currently has a robust and defined process for educating physician-users on the intended use of Prolaris and providing them with clinical support throughout the testing process," Rogers said. "Myriad will provide details of our current procedures to MolDX, to ensure proper utilization."

Importantly, the LCD requires that Myriad report any patients who are deemed to be at low risk of progression by Prolaris but experience metastases several years after diagnoses or die of prostate cancer. Myriad also must identify and report any safety concerns associated with the test.

The draft LCD will now be open for public comment for at least 45 days, after which CMS will issue a final LCD. The final version goes into effect after a 45-day notification period.

The list price for Prolaris is $3,400. Myriad does have programs that help patients pay for the test. Rogers said that Myriad has provided MolDx and Noridian the information they have requested for a pricing determination. A Medicare reimbursement price for Prolaris will not be set until the LCD is finalized, however.

The draft LCD on Prolaris follows several others issued by Palmetto for multi-analyte molecular diagnostics, including MDxHealth's ConfirmMDx, BioTheranostics Breast Cancer Index, and Assurex Health's GeneSight Psychotropic. CMS has finalized LCDs for ConfirmMDx and Breast Cancer Index.

These latest coverage schemes reflect more flexible policies to reimburse testing under specific conditions, and some policies even provide a path for test developers to garner the clinical utility data necessary for broader coverage. For example, ConfirmMDx was the first test reimbursed by Palmetto under a new "coverage with data development" protocol, which allows MDxhealth to garner payment for testing while gathering real-world clinical utility data.

On the same day that Palmetto issued a draft LCD for Prolaris, it also issued one for GenomeDx's Decipher Prostate Cancer Classifier (see related story, in this issue).

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