Reimbursement Trends: 8 Molecular Assays Score Big Coverage Wins from Medicare, Private Insurers

Molecular labs continue to gain ground with insurers. This summer, 8 more genetic assays received positive coverage decisions—4 from Medicare and 4 from private insurers. The winners included Genomic Health, CareDx, Myriad Genetics, Castle Biosciences, Interpace Diagnostics and NanoString Technologies. Here's a rundown of the key details.

The Medicare Approvals

Four of the approvals came from Medicare via the finalization of Local Coverage Determinations (LCDs) issued by principal contractor Palmetto GBA this spring. All of the determinations take effect Oct. 9.

1. Oncotype DX for Intermediate-Risk Prostate Cancer
Test: Genomic Health's Oncotype DX Genomic Prostate Score (GPS) for assessing the current state and future risk of prostate cancer.

Coverage: GPS, which is currently covered for clinically-low risk men, will also be covered for patients with favorable intermediate- risk prostate cancer under National Comprehensive Cancer Network (NCCN) guidelines. Conditions:

• Testing must be performed by physicians enrolled in a Palmetto MolDX-approved Certification and Training Registry program; and

• Physicians must monitor patients for disease progression and report cases of metastasis or prostate cancer deaths in patients who were deemed low risk by the assay.

Context: The positive coverage decision expands the number of Medicare beneficiaries eligible for the test from 50,000 to 80,000. In January 2017, Palmetto approved Myriad Genetics' Prolaris, which measures the aggressiveness of prostate cancer by analyzing 31 cell cycle progression genes, for men with favorable intermediate risk of prostate cancer under NCCN criteria.

2. AlloSure for Kidney Transplant Rejection Risks
Test: CareDx's AlloSure targeted next-generation sequencing (NGS) test for quantifying donor-derived cell-free DNA in kidney transplant recipients.

Coverage: AlloSure covered for measuring the probability of allograft rejection in kidney transplant recipients for whom there is a clinical suspicion of rejection at least two weeks post-transplant. Conditions:

• Patients must be over 18; and

• Before ordering, physicians must assess patients for probability of active renal allograft rejection.

Context: Medicare contractor Noridian has also issued but not yet finalized a positive LCD for AlloSure, which the company claims is the only non-invasive test that uses donor derived cell-free DNA as a biomarker to identify probability of active rejection and directly measure allograft injury. "Noridian typically follows Palmetto's lead relatively quickly (but can take months in some cases)," according to a CareDx source.

3. DecisionDx-UM for Uveal Melanoma Prognosis
Test: DecisionDx-UM, Castle Biosciences' test for assessing metastatic risk of uveal melanoma.

Coverage: Test covered for newly diagnosed uveal melanoma patients and to guide surveillance and referral to medical oncology.

Context: Castle announced that Aetna has also decided to cover the test. In addition, the test is covered by 14 Blue Cross Blue Shield plans in California, Florida, New Jersey, North Carolina, Michigan, Massachusetts, Washington, Oregon, Alabama, Arizona, Louisiana, Utah, Idaho and Alaska—58 million total recipients.

4. EndoPredict Test to Help Breast Cancer Patients Avoid Chemotherapy
Test: Myriad G enetics's EndoPredict, which uses a 12-gene molecular a ssessment score combined with tumor size, nodal status and other features to determine if it is medically safe for clinically low-risk breast cancer patients to skip chemo.

Coverage: EndoPredict covered only for postmenopausal women diagnosed with early-stage estrogen-receptor (ER) positive, HER2-negative breast cancer who either:

• Are lymph node-negative; or

• Have up to 3 positive nodes and are being considered for adjuvant endocrine therapy.

Context:Two other breast cancer prediction molecular assays on the market have received favorable Medicare coverage determinations from Noridian:

• Oncotype DX Breast from Genomic Health, Inc.; and

• Prosigna from Nanostring Technologies.

The Medicare Approvals

Two of the tests receiving Medicare approval described above also got the thumbs-up from private insurers, including:

5. Aetna's approval of Castle Biosciences' DecisionDx-UM for uveal melanoma assessment; and

6. Anthem's positive coverage decision for Myriad Genetics' EndoPredict breast cancer recurrence test.

Other tests gaining private insurer approval included:

7. Prosigna for Predicting Risks of Breast Cancer Recurrence
On Sept. 5, NanoString Technologies announced that Anthem had issued a positive coverage decision for the company's Prosigna assay, which provides a risk category and number score relecting a breast cancer patient's 10-year recurrence risks. Prosigna is now covered by every national commercial insurance plan in the U.S., along with a majority of regional plans, according to the company. "We now estimate that over 95 percent of U.S. patients that are indicated for Prosigna are covered."

8. ThyGenX Test for Thyroid Cancer
On July 27, Interpace Diagnostics announced Cigna will cover its ThyGenX molecular thyroid NGS test for identifying more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas. In addition to Cigna's roughly 15 million member, 260 million patients already have access to the test via Medicare, Aetna and UnitedHealthcare.

Takeaway: While positive, the recent spate of positive coverage rulings shouldn't lull anyone into a false sense of security. Coverage for newfangled molecular assays remains piecemeal and frustratingly slow to attain—especially from Medicare.