Dive Brief:
- Myriad Genetics on Monday said insurer Aetna and two other health plans have agreed to cover its Prolaris genetic test that measures tumor cell growth to provide an assessment of how quickly a patient's prostate cancer may progress. BlueCross BlueShield of Tennessee and a third insurer that Myriad did not identify by name will also cover the test.
- The decisions make Prolaris available to an additional 26 million covered lives, nearly doubling total commercial coverage for the test to 55 million lives.
- The approvals are a positive for the beleaguered molecular diagnostics company, which accepted the resignation of its veteran CEO in February after a string of disappointing earnings results. Myriad's shares climbed nearly 6% on Monday.
Dive Insight:
Already reeling from a leadership shuffle in February that came after cutting its financial outlook two quarters in a row, Salt Lake City-based Myriad was among the many medtechs hit by the COVID-19 crisis, which saw patients delay non-urgent medical care. On the company's third-quarter call in May, interim CEO Bryan Riggsbee said the pandemic had reduced test volumes by 20% to 75% across its portfolio.
The company's total revenue declined 24% in the quarter. Prolaris was a relative bright spot, with revenue slipping only 1% to $6.8 million. Although its volumes increased from the year before as the test was used more frequently, price declines along with physician office closings stifled revenue growth.
Because prostate cancer often grows slowly, doctors may recommend a "watchful waiting" approach to defer treatment, rather than removal of the prostate or radiation to destroy the cancer. The Prolaris test, used with traditional diagnostic tools such as the prostate-specific antigen screening, assesses how aggressively the cancer is likely to progress over the next 10 years to help determine the best treatment option.
Other array-based gene expression profiling tests on the market include Genomic Health's Oncotype Dx Prostate Cancer Assay (now owned by Exact Sciences), Decipher Biosciences' Decipher Prostate Cancer Classifier, and Metamark Genetics' ProMark Protein Biomarker test, according to BlueCross BlueShield of Tennessee.
Myriad is also working to expand coverage for its GeneSight psychotropic combinatorial test. Last week, the company announced that Palmetto GBA, an administrative contractor for Medicare, issued a final local coverage determination (LCD) for pharmacogenomic testing across a range of psychiatric conditions.
Palmetto said insufficient data exists to support coverage for combinatorial tests. However, Myriad said details of the LCD's application to GeneSight await action by CGS Administrators, the Medicare contractor for the test. “We believe GeneSight is covered under the new LCD as a multi-gene panel and await a Local Coverage Article for GeneSight and specific action by CGS," Mark Verratti, president of Myriad Neuroscience and Myriad Autoimmune, said in a statement.