Myriad Genetics Provides Update on Discussions with UnitedHealthcare regarding Medical Policy for Pharmacogenetic Testing
Rhea-AI Summary
Myriad Genetics provided an update regarding its discussions with UnitedHealthcare (UNH) following UNH's November 1 policy update that restricts access to multi-gene panel pharmacogenetic tests, including Myriad's GeneSight test, effective January 1, 2025. The company has been engaging in dialogue with UNH, presenting additional clinical data supporting GeneSight's clinical validity and utility, particularly for primary care settings where most antidepressants are prescribed.
Myriad has requested continued access to the test for UHC enrollees in 2025. While aiming for a year-end resolution, discussions may extend into early 2025. The company maintains its previously announced 2024 financial impact estimates related to UNH's policy change.
Positive
- Actively engaging in constructive dialogue with UnitedHealthcare
- Presenting additional clinical data for review
- Maintains previously announced financial guidance
Negative
- UnitedHealthcare restricting access to GeneSight test from January 1, 2025
- Potential revenue impact from UNH coverage restriction
- Resolution uncertainty extending into 2025
Insights
The UnitedHealthcare policy change poses a significant business risk for Myriad Genetics' GeneSight test revenue stream. The restriction of access to multi-gene panel pharmacogenetic tests under UNH's commercial and individual exchange benefit plans could materially impact Myriad's financials starting January 2025. While constructive dialogue is ongoing, the lack of immediate resolution creates uncertainty.
The fact that Myriad is maintaining its previously stated financial impact estimates from the Q3 earnings call suggests the company has a clear view of the potential downside. The primary care setting focus is particularly concerning as it represents a major market for antidepressant prescriptions. This policy change could affect both near-term revenues and long-term market positioning in the pharmacogenetic testing space.
UnitedHealthcare's policy shift reflects broader industry scrutiny of pharmacogenetic testing reimbursement. The timing of this update, affecting coverage from January 2025, gives runway for Myriad to secure policy modifications. The company's emphasis on presenting additional clinical data suggests a strategy focused on demonstrating enhanced clinical utility and validity.
The delay in discussions due to the tragic loss of UHC's CEO adds another layer of complexity to an already time-sensitive situation. If resolution extends into 2025, it could create a coverage gap affecting patient access and provider adoption patterns. The outcome of these discussions could set precedents for other insurers' coverage policies regarding pharmacogenetic testing.
SALT LAKE CITY, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today provided an update on its engagement with UnitedHealthcare (UNH) following the Nov 1, 2024 publication of its updated medical policy restricting access to multi-gene panel pharmacogenetic tests, including Myriad’s GeneSight test, under its commercial and individual exchange benefit plans, effective January 1, 2025.
Since the announcement, Myriad has actively engaged in constructive dialogue with UNH regarding the clinical evidence supporting Myriad’s proprietary and clinically differentiated mental health medication test, GeneSight, including presenting additional clinical data to UnitedHealthcare for its further review and consideration. Myriad has requested that UHC enrollees continue to have access to the test in 2025, especially in the primary care setting where a significant majority of antidepressants are prescribed 1.
“Following the tragic death of UnitedHealthcare CEO Brian Thompson on December 4th, we extend our deepest condolences to Brian’s family and all employees of UnitedHealthcare. Soon, at the appropriate time, we plan to continue our dialogue with UNH and other key stakeholders,” said Paul J. Diaz, President and CEO, Myriad Genetics. “We desire resolution ahead of year-end, but discussions may extend into early 2025. We remain steadfast in our confidence in the clinical validity and utility of GeneSight, which we believe is supported by clinical evidence, including peer-reviewed research studies.”
During Myriad’s third quarter earnings call held on November 6, 2024, the company provided an estimate of the 2024 financial impact of UNH’s updated medical policy. While Myriad continues to engage with UNH, the company reaffirms this estimate.
About the GeneSight® Psychotropic Test
The GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for more than 60 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The GeneSight test can help inform clinicians about how a patient’s genes may impact how they metabolize and/or respond to certain psychiatric medications. Tens of thousands of clinicians have ordered the GeneSight test for almost three million patients in order to receive genetic information that is unique to each patient. The GeneSight test supplements other information considered by a clinician as part of a comprehensive medical assessment. The clinical validity, clinical utility and economic utility of the GeneSight test have been evaluated in multiple peer-reviewed publications. Learn more at GeneSight.com.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s plan to continue its dialogue with UNH and other key stakeholders and the company’s confidence in the clinical validity and utility of GeneSight, which the company believes is supported by clinical evidence, including peer-reviewed research studies. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.
1 Majtabai R, et al. J Clin Psychiatry. 2008 Jul;69(7):106574.
Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com
Media Contact
Glenn Farrell
(385) 318-3718
PR@myriad.com
FAQ
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