Myriad Genetics Provides Update on Discussions with UnitedHealthcare regarding Medical Policy for Pharmacogenetic Testing
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.
Myriad Genetics ha fornito un aggiornamento riguardo le sue discussioni con UnitedHealthcare (UNH) in seguito all'aggiornamento della politica di UNH del 1 novembre che limita l'accesso ai test farmacogenetici a pannello multiplo, inclusi il test GeneSight di Myriad, a partire dal 1 gennaio 2025. L'azienda ha avviato un dialogo con UNH, presentando ulteriori dati clinici a supporto della validità e utilità clinica di GeneSight, in particolare per i contesti di medicina primaria dove la maggior parte degli antidepressivi viene prescritta.
Myriad ha richiesto un accesso continuato al test per i membri UHC nel 2025. Pur mirando a una risoluzione entro la fine dell'anno, le discussioni potrebbero estendersi all'inizio del 2025. L'azienda mantiene le sue stime sull'impatto finanziario per il 2024 precedentemente annunciate in relazione alla modifica della politica di UNH.
Myriad Genetics proporcionó una actualización sobre sus discusiones con UnitedHealthcare (UNH) tras la actualización de la política de UNH del 1 de noviembre, que restringe el acceso a pruebas farmacogenéticas de panel múltiple, incluyendo la prueba GeneSight de Myriad, a partir del 1 de enero de 2025. La empresa ha estado dialogando con UNH, presentando datos clínicos adicionales que respaldan la validez y utilidad clínica de GeneSight, particularmente en entornos de atención primaria donde se prescriben la mayoría de los antidepresivos.
Myriad ha solicitado un acceso continuo a la prueba para los inscritos de UHC en 2025. Si bien busca una resolución para fin de año, las discusiones podrían extenderse hasta principios de 2025. La empresa mantiene sus estimaciones anteriores sobre el impacto financiero para 2024 relacionadas con el cambio de política de UNH.
Myriad Genetics는 UnitedHealthcare (UNH)와의 논의에 대한 업데이트를 제공했습니다. 이는 UNH의 11월 1일 정책 업데이트로, GeneSight 검사를 포함한 다유전자 패널의 약물 유전체 검사 접근을 제한하는 내용으로, 2025년 1월 1일부터 시행됩니다. 이 회사는 UNH와의 대화에서 GeneSight의 임상 유효성과 유용성을 지원하는 추가 임상 데이터를 제시하고 있으며, 특히 대부분의 항우울제가 처방되는 일차 진료 환경에서의 활용을 강조하고 있습니다.
Myriad는 2025년 UHC 참가자에 대한 검사의 지속적인 접근을 요청했습니다. 연말 해결을 목표로 하고 있지만, 논의는 2025년 초까지 연장될 수 있습니다. 이 회사는 UNH의 정책 변경과 관련하여 이전에 발표한 2024년 재정적 영향 추정치를 유지하고 있습니다.
Myriad Genetics a fourni une mise à jour concernant ses discussions avec UnitedHealthcare (UNH) suite à la mise à jour de la politique d'UNH du 1er novembre qui limite l'accès aux tests pharmacogénétiques à panel multiple, y compris le test GeneSight de Myriad, à compter du 1er janvier 2025. L'entreprise a engagé un dialogue avec UNH, présentant des données cliniques supplémentaires soutenant la validité clinique et l'utilité de GeneSight, en particulier pour les soins primaires où la plupart des antidépresseurs sont prescrits.
Myriad a demandé un accès continu au test pour les adhérents de l'UHC en 2025. Bien visant une résolution d'ici la fin de l'année, les discussions pourraient s'étendre au début de 2025. L'entreprise maintient ses estimations d'impact financier pour 2024 liées au changement de politique d'UNH précédemment annoncées.
Myriad Genetics hat ein Update zu seinen Gesprächen mit UnitedHealthcare (UNH) gegeben, nachdem UNH am 1. November eine Richtlinienaktualisierung veröffentlicht hat, die den Zugang zu multiplen genetischen Panel-Pharmakogenetik-Tests, einschließlich GeneSight-Test von Myriad, ab dem 1. Januar 2025 einschränkt. Das Unternehmen hat den Dialog mit UNH gesucht und zusätzliche klinische Daten präsentiert, die die klinische Validität und Nützlichkeit von GeneSight unterstützen, insbesondere in der primären medizinischen Versorgung, wo die meisten Antidepressiva verschrieben werden.
Myriad hat einen fortgesetzten Zugang zu dem Test für UHC-Versicherte im Jahr 2025 beantragt. Obwohl eine Lösung bis Ende des Jahres angestrebt wird, könnten die Gespräche bis Anfang 2025 andauern. Das Unternehmen hält an seinen zuvor angekündigten finanziellen Auswirkungen für 2024 in Bezug auf die Änderung der UNH-Politik fest.
- Actively engaging in constructive dialogue with UnitedHealthcare
- Presenting additional clinical data for review
- Maintains previously announced financial guidance
- 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.
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FAQ
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