Prolaris Certification and Training Registry Program Guide

New MolDX LCD ID: DL35844 Prolaris Certification and Training Registry

Program Guide

Prolaris? Certification and Training Registry (Prolaris CTR)

This Program Guide provides a step-by-step overview of the operational aspects of the Prolaris CTR, including how to (1) enroll as a healthcare provider and receive training on appropriate use of Prolaris testing, (2) report any adverse events as a result of using Prolaris (3) counsel and appropriately monitor your Medicare patients who have received Prolaris testing.

Because of the complicated nature of management decisions using Prolaris testing and the potential for adverse harm to patients if the test is not used appropriately, only physicians who are enrolled in the Prolaris CTR program will have access to Prolaris testing for Medicare Beneficiaries.

The goal of the Prolaris Certification and Training Program is to ensure that the benefits of the Prolaris test outweigh any of its risks by:

Ensuring that physicians understand the limitations of the test based on its validation through retrospective and non-U.S. standard of care studies, and

Informing prescribers and patients on the safe-use conditions for Prolaris , and Ensuring appropriate selection of patients, compliance with management decisions, and Make a good faith effort to identify any safety concerns from the use of the test

Prolaris CTR Materials:

A. Program Guide .................................................Pages 1-2 B. Training Package...............................................Pages 3-9 C. Sample Test Requisition Form (TRF)............Page 10-11 D. Healthcare Provider Enrollment (Form 1)........Page 12 E. Adverse Event Report (Form 2)..........................Page 13 F. Patient Guide........................................................Page 14 G.

As the sponsor of Prolaris CTR, Myriad Genetic Laboratories has committed to working with healthcare providers to ensure compliance with the registry requirements and to assist in gathering and reporting relevant data to the MolDX program within Palmetto GBA.

Please keep this copy for your files

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MolDX LCD ID: DL35844 Prolaris Certification and Training Registry

Program Guide

Prolaris? Certification and Training Registry (Prolaris CTR)

1. Healthcare Provider Enrollment: a. Carefully review all Prolaris CTR program documents b. Complete necessary training, including live physician-to-physician webinar or ondemand video and materials on c. Complete Healthcare Provider Enrollment form (page 12) and give to your Myriad representative, fax to Myriad Genetic Laboratories at (801) 883-3256, email to ProlarisCS@, or complete form on

2. Prolaris Testing: a. Prolaris testing is covered by Medicare for very low- and low-risk patients, based on National Comprehensive Cancer Network (NCCN) risk criteria (AUA low risk) b. The healthcare provider must be enrolled in the Prolaris CTR and complete a Test Requisition Form to order Prolaris for Medicare Beneficiaries c. Patients should be appropriately counseled on: i. Benefits and risks of Prolaris testing ii. Prolaris test results iii. Need for additional follow-up and appropriate treatment options d. Report adverse outcomes for Medicare beneficiaries tested with Prolaris, as required by the CTR

3. Observational Data Collection/Reporting: a. Immediately report any metastases or prostate cancer deaths in patients who did not receive definitive therapy who were deemed low risk by the assay b. A cumulative list will be sent to each enrolled healthcare provider every six months, showing their tested AUA low risk (NCCN very low- and low- risk) patients with low Prolaris scores for use in checking for adverse events. c. Fully complete the Adverse Event Report (AER) Form (page 13) and fax to Myriad Genetic Laboratories at (801) 883-3256 or email to ProlarisCS@. This form can also be downloaded on

4. Program Compliance: a. The LCD(s) providing coverage for Prolaris require healthcare providers to comply with all obligations of the Prolaris CTR in order to maintain their certification b. As sponsor of the Prolaris CTR, Myriad Genetic Laboratories may contact you from timeto-time to assure your continued compliance with the Prolaris CTR and to provide any necessary ongoing provider and/or patient education c. In the event of a continued failure to remain in compliance with the terms of the LCD and the Prolaris CTR, Myriad Genetic Laboratories is charged with taking appropriate measures to bring registered healthcare providers into compliance, including by instituting corrective actions up to and including de-certification

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MolDX LCD ID: DL35844 Prolaris Certification and Training Registry

Training Package

Prolaris? Certification and Training Registry (Prolaris CTR)

The Prolaris Certification and Training Registry (CTR) has been established to enable Medicare coverage for eligible patients. Under Local Coverage Determination (LCD) DL35844, the Prolaris test is considered "reasonable and necessary" for Medicare patients meeting identified coverage criteria and when ordered by a physician certified in the CTR.

Section 1. Overview of the Prolaris Test

Prolaris Test Description ProlarisTM is an RNA based assay measuring the expression of 31 cell cycle progression (CCP) genes and 15 "housekeeping" genes that act as internal controls and normalization standards in each patient sample. The assay is performed on formalin fixed paraffin-embedded (FFPE) prostate cancer blocks. The assay results are reported as a numerical score along with accompanying interpretive information.

Prolaris Test Performance The clinical performance of this assay was assessed in several retrospective validation studies. These include two British cohorts of men diagnosed with prostate cancer on biopsy and then treated conservatively; and an additional cohort of men diagnosed by TURP and conservatively managed. Further validation was performed in various other cohorts including men who underwent radical prostatectomy, and men treated with definitive radiotherapy. The ProlarisTM cell cycle progression score (CCP) was found to be an independent and more robust prognostic factor for disease related death than traditional clinicopathologic factors although disease stage and Gleason score consistently portended a more negative prognostic picture.

Section 2. Limitations of the Prolaris Test

Due to the difficulty in obtaining prospective data in early prostate cancer, and given the unmet need, clinical utility can be extrapolated from retrospective data. Doing so is not without shortcomings. Within the British cohorts, it is unclear who went on to receive definitive therapy inside the observation groups. The U.K. standard of care for treating these prostate cancer patients is different. In the U.S., conservative management of patients is not the common occurrence. However, given the long time period to determine outcomes, similar analysis of a U.S. cohort is unlikely and not possible for many years.

In several of the published cohorts including the conservatively managed patients, multivariate analysis identified CCP score and Gleason score as the only values that consistently identify increased risk of death from prostate cancer. It also should be noted that the cancer related death rate in these retrospective studies of conservatively managed patients was much greater than would be expected in the United States. It is assumed that if the patients with higher risk disease (Gleason score > 7; higher

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stage) had received definitive treatment (like the current standard in the US) the rate succumbing to disease would likely be substantially better.

The potential usefulness of this test is that it allows physicians to determine which patients with early prostate cancer are candidates for active surveillance or observation and are more likely to have a good outcome without needing to receive definitive treatment. Conversely men who have more aggressive malignancy despite favorable clinicopathologic parameters can be counseled for curative therapy.

Section 3. Important Safety Information

The mortality risk reported by Prolaris for each patient is based on retrospective evaluations of biopsy specimens from conservatively-managed cohorts combined with clinico-pathologic features, and is intended to help refine risk assessment. It has not been evaluated in a prospective trial. Specific therapeutic decisions should take into account all relevant clinical parameters including a patient's age and overall health. All patients receiving Prolaris results should be monitored for disease progression per established standards-of-care.

Section 4. Patient Eligibility - Indications for Use Under Prolaris LCD ID DL35844

The ProlarisTM assay is covered by Medicare only when the following clinical conditions are met:

Needle biopsy diagnosis of clinically localized adenocarcinoma of the prostate (no clinical evidence of metastasis lymph node involvement or extension beyond the gland), and

FFPE prostate biopsy specimen with at least 0.5 mm of cancer length, and Patient Stage as defined by the one of the following:

o Very Low Risk Disease (T1c AND Gleason Score 6 AND PSA 10 ng/mL AND ................
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